{"version":"52f637a50d","generatedAt":"2026-11-05T07:19:06.777Z","emaTimestamp":"2026-11-05T06:02:18Z","pipeline":{"readerA":"google/gemini-3.8-flash","readerB":"openai/gpt-6-luna","checker":"typesafe/jev-1.14","judge":"anthropic/claude-opus-5.5","jevDissent":0.9},"products":[{"key":"zanubrutinib__brukinsa","inn":"zanubrutinib","brand":"Brukinsa","company":"BeOne Medicines Netherlands B. V.","ema_product_number":"EMEA/H/C/004978","atc_code":"L01EL03","authorised":"2021-11-22","pi_updated":"2026-11-04","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/brukinsa","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/brukinsa-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/brukinsa-epar-product-information_de.pdf","indication_text":"BRUKINSA as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.\nBRUKINSA as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.\nBRUKINSA as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL).\nBRUKINSA in combination with obinutuzumab is indicated for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.","extracted":true,"target":{"targets":["BTK"],"modality":"small molecule","label":"BTK inhibitor","mechanism":"Zanubrutinib covalently binds and inhibits Bruton's tyrosine kinase, blocking B-cell receptor signalling pathways essential for B-cell proliferation, trafficking, and chemotaxis.","quote":"Zanubrutinib is an inhibitor of Bruton’s tyrosine kinase (BTK).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/brukinsa-epar-product-information_en.pdf"},"copies":[]},{"key":"entrectinib__rozlytrek","inn":"entrectinib","brand":"Rozlytrek","company":"Roche Registration GmbH ","ema_product_number":"EMEA/H/C/004936","atc_code":"L01EX14","authorised":"2020-07-31","pi_updated":"2026-11-03","conditional":true,"exceptional":false,"orphan":false,"prime":true,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/rozlytrek","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/rozlytrek-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/rozlytrek-epar-product-information_de.pdf","indication_text":"Neurotrophic tyrosine receptor kinase (NTRK) gene fusion\nRozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients older than 1 month with solid tumours that have a NTRK gene fusion,  who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and  who have not received a prior NTRK inhibitor  who have no satisfactory treatment options (see sections 4.4 and 5.1).\nROS1 gene fusion\nRozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.","extracted":true,"target":{"targets":["TRKA","TRKB","TRKC","ROS1","ALK"],"modality":"small molecule","label":"TRK/ROS1/ALK inhibitor","mechanism":"Entrectinib inhibits the TRKA, TRKB, TRKC, ROS1 and ALK tyrosine kinases, blocking downstream signalling and cell proliferation driven by NTRK, ROS1 or ALK fusion proteins.","quote":"Entrectinib is an inhibitor of the tropomyosin receptor tyrosine kinases TRKA, TRKB and TRKC (encoded by the neurotrophic tyrosine receptor kinase [NTRK] genes NTRK1, NTRK2 and NTRK3, respectively), proto-oncogene tyrosine-protein kinase ROS (ROS1), and anaplastic lymphoma kinase (ALK), with IC50 values of 0.1 to 2 nM.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/rozlytrek-epar-product-information_en.pdf"},"copies":[]},{"key":"pembrolizumab__keytruda","inn":"pembrolizumab","brand":"Keytruda","company":"Merck Sharp & Dohme B.V.","ema_product_number":"EMEA/H/C/003820","atc_code":"L01FF02","authorised":"2015-07-17","pi_updated":"2026-10-30","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/keytruda","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/keytruda-epar-product-information_de.pdf","indication_text":"Melanoma\nKEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma.\nKEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection (see section 5.1).\nNon-small cell lung carcinoma (NSCLC)\nKEYTRUDA, in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung carcinoma at high risk of recurrence in adults (for selection criteria, see section 5.1).\nKEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum-based chemotherapy (for selection criteria, see section 5.1).\nKEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.\nKEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous non-small cell lung carcinoma in adults whose tumours have no EGFR or ALK positive mutations.\nKEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous non-small cell lung carcinoma in adults.\nKEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a ≥ 1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA.\nMalignant pleural mesothelioma (MPM)\nKEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma.\nClassical Hodgkin lymphoma (cHL)\nKEYTRUDA as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option.\nUrothelial carcinoma\nKEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).\nKEYTRUDA, in combination with enfortumab vedotin, is indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults.\nKEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy (see section 5.1).\nKEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10 (see section 5.1).\nHead and neck squamous cell carcinoma (HNSCC)\nKEYTRUDA as monotherapy is indicated for the treatment of resectable locally advanced head and neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumours express PD-L1 with a CPS ≥ 1.\nKEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 (see section 5.1).\nKEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinum-containing chemotherapy (see section 5.1).\nRenal cell carcinoma (RCC)\nKEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1).\nKEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1).\nKEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, see section 5.1).\nMicrosatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers Colorectal cancer (CRC) KEYTRUDA as monotherapy is indicated for adults with MSI-H or dMMR colorectal cancer in the following settings:\n- first-line treatment of metastatic colorectal cancer;\n- treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine-based combination therapy.\nNon-colorectal cancers\nKEYTRUDA as monotherapy is indicated for the treatment of the following MSI-H or dMMR tumours in adults with:\n- advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation;\n- unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.\nOesophageal carcinoma\nKEYTRUDA, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus in adults whose tumours express PD-L1 with a CPS ≥ 10 (see section 5.1).\nTriple-negative breast cancer (TNBC)\nKEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence (see section 5.1).\nKEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease (see section 5.1).\nEndometrial carcinoma (EC)\nKEYTRUDA, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy.\nKEYTRUDA, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation.\nCervical cancer\nKEYTRUDA, in combination with chemoradiotherapy (external beam radiation therapy followed by brachytherapy), is indicated for the treatment of FIGO 2014 Stage III - IVA locally advanced cervical cancer in adults who have not received prior definitive therapy.\nKEYTRUDA, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS ≥ 1.\nGastric or gastro-oesophageal junction (GEJ) adenocarcinoma\nKEYTRUDA, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1.\nKEYTRUDA, in combination with fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 (see section 5.1).\nBiliary tract carcinoma (BTC)\nKEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults.\nOvarian Cancer\nKEYTRUDA, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 and who have received one or two prior systemic treatment regimens.\nKEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option.","extracted":true,"target":{"targets":["PD-1"],"modality":"monoclonal antibody","label":"PD-1 inhibitor (antibody)","mechanism":"Pembrolizumab binds to the PD-1 receptor, blocking interaction with PD-L1 and PD-L2 to potentiate T-cell anti-tumour immune responses.","quote":"KEYTRUDA is a humanised monoclonal antibody which binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with ligands PD-L1 and PD-L2.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf"},"copies":[]},{"key":"ciltacabtagene-autoleucel__carvykti","inn":"ciltacabtagene autoleucel","brand":"Carvykti","company":"Janssen-Cilag International NV","ema_product_number":"EMEA/H/C/005095","atc_code":"L01XL05","authorised":"2022-05-25","pi_updated":"2026-10-29","conditional":false,"exceptional":false,"orphan":true,"prime":true,"advanced_therapy":true,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/carvykti","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/carvykti-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/carvykti-epar-product-information_de.pdf","indication_text":"CARVYKTI is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.","extracted":true,"target":{"targets":["BCMA"],"modality":"cell therapy","label":"BCMA-directed CAR T-cell therapy","mechanism":"Autologous T cells engineered with a CAR targeting BCMA bind BCMA-expressing cells to promote T-cell activation, expansion, and elimination of target cells.","quote":"CARVYKTI is a BCMA-directed, genetically modified autologous T cell immunotherapy, which involves reprogramming a patient’s own T cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/carvykti-epar-product-information_en.pdf"},"copies":[]},{"key":"dinutuximab-beta__qarziba-previously-dinutuximab-beta-eusa-and-dinutuximab-beta-apeiron-","inn":"dinutuximab beta","brand":"Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)","company":"Recordati Netherlands B.V.","ema_product_number":"EMEA/H/C/003918","atc_code":"L01FX06","authorised":"2017-05-08","pi_updated":"2026-10-29","conditional":false,"exceptional":true,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/qarziba","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/qarziba-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/qarziba-epar-product-information_de.pdf","indication_text":"Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures.\nIn patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, Qarziba should be combined with interleukin-2 (IL-2).","extracted":true,"target":{"targets":["GD2"],"modality":"monoclonal antibody","label":"Anti-GD2 monoclonal antibody","mechanism":"Dinutuximab beta is a chimeric monoclonal IgG1 antibody specifically directed against the carbohydrate moiety of disialoganglioside 2 (GD2) overexpressed on neuroblastoma cells.","quote":"Dinutuximab beta is a chimeric monoclonal IgG1 antibody that is specifically directed against the carbohydrate moiety of disialoganglioside 2 (GD2), which is overexpressed on neuroblastoma cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/qarziba-epar-product-information_en.pdf"},"copies":[]},{"key":"nivolumab__opdivo","inn":"nivolumab","brand":"Opdivo","company":"Bristol-Myers Squibb Pharma EEIG","ema_product_number":"EMEA/H/C/003985","atc_code":"L01FF01","authorised":"2015-06-19","pi_updated":"2026-10-29","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/opdivo","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/opdivo-epar-product-information_de.pdf","indication_text":"Melanoma\nOPDIVO as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with Stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection (see section 5.1).\nOPDIVO as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older.\nRelative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1).\nNon-small cell lung cancer (NSCLC)\nOPDIVO in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria).\nOPDIVO in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by OPDIVO as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria).\nOPDIVO in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.\nOPDIVO as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults.\nMalignant pleural mesothelioma (MPM)\nOPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.\nRenal cell carcinoma (RCC)\nOPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1).\nOPDIVO in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (see section 5.1).\nOPDIVO as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults.\nClassical Hodgkin lymphoma (cHL)\nOPDIVO in combination with doxorubicin, vinblastine and dacarbazine (AVD) is indicated for adults and adolescents 12 years of age and older with previously untreated Stage III or IV classical Hodgkin lymphoma.\nOPDIVO in combination with brentuximab vedotin is indicated for the treatment of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory classical Hodgkin lymphoma after one prior line of therapy (see section 5.1).\nOPDIVO as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin.\nSquamous cell cancer of the head and neck (SCCHN)\nOPDIVO as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy (see section 5.1).\nUrothelial carcinoma (UC)\nOPDIVO as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of MIUC (see section 5.1).\nOPDIVO in combination with cisplatin and gemcitabine is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.\nOPDIVO as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.\nMismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) OPDIVO in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the following settings:\n- first-line treatment of unresectable or metastatic colorectal cancer;\n- treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy (see section 5.1).\nOesophageal squamous cell carcinoma (OSCC)\nOPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.\nOPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.\nOPDIVO as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy.\nAdjuvant treatment of oesophageal or gastro-oesophageal junction cancer (OC or GEJC) OPDIVO as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (see section 5.1).\nGastric, gastro-oesophageal junction (GEJ) or oesophageal adenocarcinoma OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5.\nHepatocellular carcinoma (HCC)\nOPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.\nOPDIVO as monotherapy is indicated for the adjuvant treatment of adults with Stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection (see section 5.1).\nOPDIVO as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults (see section 4.2).\nOPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see sections 4.2 and 5.1).\nOPDIVO in combination with cisplatin and gemcitabine is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (see sections 4.2 and 5.1).\n- first-line treatment of unresectable or metastatic colorectal cancer (see sections 4.2 and 5.1);\n- treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy (see sections 4.2 and 5.1).","extracted":true,"target":{"targets":["PD-1"],"modality":"monoclonal antibody","label":"PD-1 inhibitor (antibody)","mechanism":"Binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, potentiating anti-tumour T-cell responses.","quote":"Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (HuMAb), which binds to the programmed death-1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf"},"copies":[]},{"key":"avapritinib__ayvakyt","inn":"avapritinib","brand":"Ayvakyt","company":"Blueprint Medicines (Netherlands) B.V.","ema_product_number":"EMEA/H/C/005208","atc_code":"L01EX18","authorised":"2020-09-24","pi_updated":"2026-10-29","conditional":true,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ayvakyt","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/ayvakyt-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/ayvakyt-epar-product-information_de.pdf","indication_text":"Unresectable or metastatic gastrointestinal stromal tumour (GIST)\nAYVAKYT is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) harbouring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation.\nAdvanced systemic mastocytosis (AdvSM)\nAYVAKYT is indicated as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated haematological neoplasm (SM-AHN) or mast cell leukaemia (MCL), after at least one systemic therapy.\nIndolent systemic mastocytosis (ISM)\nAYVAKYT is indicated for the treatment of adult patients with indolent systemic mastocytosis (ISM) with moderate to severe symptoms inadequately controlled on symptomatic treatment (see section 5.1).","extracted":true,"target":{"targets":["PDGFRA","KIT"],"modality":"small molecule","label":"PDGFRA and KIT kinase inhibitor","mechanism":"Avapritinib is a type 1 kinase inhibitor that targets mutant PDGFRA and KIT, inhibiting receptor autophosphorylation and the proliferation of tumor cells harboring these mutations.","quote":"Avapritinib is a Type 1 kinase inhibitor that has demonstrated biochemical in vitro activity on the PDGFRA D842V and KIT D816V mutants associated with resistance to imatinib, sunitinib and regorafenib with half maximal inhibitory concentrations (IC50) of 0.24 nM and 0.27 nM, respectively, and greater potency against clinically relevant KIT exon 11, KIT exon 11/17 and KIT exon 17 mutants than against the KIT wild-type enzyme.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/ayvakyt-epar-product-information_en.pdf"},"copies":[]},{"key":"imatinib__glivec","inn":"imatinib","brand":"Glivec","company":"Novartis Europharm Limited","ema_product_number":"EMEA/H/C/000406","atc_code":"L01EA01","authorised":"2001-11-07","pi_updated":"2026-10-27","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/glivec","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/glivec-epar-product-information_de.pdf","indication_text":"Glivec is indicated for the treatment of\n• adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.\n• adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.\n• adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.\n• adult patients with relapsed or refractory Ph+ ALL as monotherapy.\n• adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.\n• adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR rearrangement.\nThe effect of Glivec on the outcome of bone marrow transplantation has not been determined.\nGlivec is indicated for\n• the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).\n• the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.\n• the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.\nIn adult and paediatric patients, the effectiveness of Glivec is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic GIST and DFSP and on recurrence-free survival in adjuvant GIST. The experience with Glivec in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1). Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.","extracted":true,"target":{"targets":["BCR-ABL","KIT","PDGFRA","PDGFRB","DDR1/DDR2","CSF1R"],"modality":"small molecule","label":"BCR-ABL tyrosine kinase inhibitor","mechanism":"Imatinib inhibits the BCR-ABL tyrosine kinase and the receptor kinases KIT, PDGFRα/β, DDR1/DDR2 and CSF-1R, blocking cellular events driven by their activation.","quote":"Imatinib is a small molecule protein-tyrosine kinase inhibitor that potently inhibits the activity of the Bcr-Abl tyrosine kinase (TK), as well as several receptor TKs: Kit, the receptor for stem cell factor (SCF) coded for by the c-Kit proto-oncogene, the discoidin domain receptors (DDR1 and DDR2), the colony stimulating factor receptor (CSF-1R) and the platelet-derived growth factor receptors alpha and beta (PDGFR-alpha and PDGFR-beta).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf"},"copies":[{"brand":"Imatinib Accord","company":"Accord Healthcare S.L.U.","kind":"generic","authorised":"2013-06-30","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/imatinib-accord"},{"brand":"Imatinib Teva","company":"Teva B.V.","kind":"generic","authorised":"2013-01-07","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/imatinib-teva"}]},{"key":"avelumab__bavencio","inn":"avelumab","brand":"Bavencio","company":"Merck Europe B.V.","ema_product_number":"EMEA/H/C/004338","atc_code":"L01FF04","authorised":"2017-09-18","pi_updated":"2026-05-21","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/bavencio","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/bavencio-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/bavencio-epar-product-information_de.pdf","indication_text":"Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).\nBavencio is indicated as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy.\nBavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) (see section 5.1).","extracted":true,"target":{"targets":["PD-L1"],"modality":"monoclonal antibody","label":"PD-L1 inhibitor (antibody)","mechanism":"A human IgG1 monoclonal antibody that binds PD-L1, blocking interaction with PD-1 and B7.1 to restore anti-tumour T-cell responses and induce tumour cell lysis via ADCC.","quote":"Avelumab is a human immunoglobulin G1 (IgG1) monoclonal antibody directed against programmed death ligand 1 (PD-L1).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/bavencio-epar-product-information_en.pdf"},"copies":[]},{"key":"sugemalimab__cejemly","inn":"sugemalimab","brand":"Cejemly","company":"Cstone Pharmaceuticals Ireland Limited","ema_product_number":"EMEA/H/C/006088","atc_code":"L01FF11","authorised":"2024-07-24","pi_updated":"2026-10-22","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/cejemly","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/cejemly-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/cejemly-epar-product-information_de.pdf","indication_text":"Cejemly in combination with platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small-cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations.\nCejemly as monotherapy is indicated for the treatment of unresectable stage III NSCLC with no sensitising EGFR mutations, or ALK, ROS1 genomic tumour aberrations in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiotherapy.","extracted":true,"target":{"targets":["PD-L1"],"modality":"monoclonal antibody","label":"PD-L1 inhibitor (antibody)","mechanism":"Sugemalimab binds to PD-L1, blocking its interactions with PD-1 and CD80 to release the inhibition of anti-tumour immune responses.","quote":"It specifically binds to programmed cell death ligand 1 (PD-L1), thus blocking its ligation with PD-1.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/cejemly-epar-product-information_en.pdf"},"copies":[]},{"key":"trastuzumab__tuznue","inn":"trastuzumab","brand":"Tuznue","company":"Prestige Biopharma Belgium","ema_product_number":"EMEA/H/C/006252","atc_code":"L01FD01","authorised":"2024-09-19","pi_updated":"2026-07-14","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tuznue","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/tuznue-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/tuznue-epar-product-information_de.pdf","indication_text":"Breast cancer\nMetastatic breast cancer\nTuznue is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):\n- as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.\n- in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.\n- in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.\n- in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.\nEarly breast cancer\nTuznue is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC):\n- following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1).\n- following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.\n- in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.\n- in combination with neoadjuvant chemotherapy followed by adjuvant Tuznue therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4. and 5.1).\nTuznue should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1) Metastatic gastric cancer Tuznue in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.\nTuznue should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC 2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result. Accurate and validated assay methods should be used (see sections 4.4 and 5.1).","extracted":true,"target":{"targets":["HER2"],"modality":"monoclonal antibody","label":"HER2-directed monoclonal antibody","mechanism":"Binds HER2's extracellular domain to inhibit ligand-independent signalling, prevent extracellular domain cleavage, and mediate antibody-dependent cell-mediated cytotoxicity against HER2-overexpressing tumour cells.","quote":"Trastuzumab binds with high affinity and specificity to sub-domain IV, a juxta-membrane region of HER2’s extracellular domain.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/tuznue-epar-product-information_en.pdf"},"copies":[{"brand":"Kanjinti","company":"Amgen Europe B.V.","kind":"biosimilar","authorised":"2018-05-16","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/kanjinti"},{"brand":"Ontruzant","company":"Samsung Bioepis NL B.V.","kind":"biosimilar","authorised":"2017-11-15","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ontruzant"},{"brand":"Zercepac","company":"Accord Healthcare S.L.U.","kind":"biosimilar","authorised":"2020-07-27","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zercepac"},{"brand":"Herzuma","company":"Celltrion Healthcare Hungary Kft.","kind":"biosimilar","authorised":"2018-02-09","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/herzuma"},{"brand":"Herwenda","company":"Sandoz GmbH","kind":"biosimilar","authorised":"2023-11-15","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/herwenda"},{"brand":"Trazimera","company":"Pfizer Europe MA EEIG","kind":"biosimilar","authorised":"2018-07-26","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/trazimera"},{"brand":"Dazublys","company":"CuraTeQ Biologics (Malta) Limited","kind":"biosimilar","authorised":"2025-06-30","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/dazublys"},{"brand":"Ogivri","company":"Biosimilar Collaborations Ireland Limited","kind":"biosimilar","authorised":"2018-12-12","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ogivri"}]},{"key":"trastuzumab__herceptin","inn":"trastuzumab","brand":"Herceptin","company":"Roche Registration GmbH","ema_product_number":"EMEA/H/C/000278","atc_code":"L01FD01","authorised":"2000-08-28","pi_updated":"2025-11-25","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/herceptin","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/herceptin-epar-product-information_de.pdf","indication_text":"Breast cancer\nMetastatic breast cancer\nHerceptin is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer:\n(MBC):\n- as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.\n- in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.\n- in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.\n- in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.\nEarly breast cancer\nHerceptin is indicated for the treatment of adult patients with HER2 positive early breast cancer.\n(EBC).\n- following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1).\n- following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.\n- in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.\n- in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1).\nHerceptin should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1).\nMetastatic gastric cancer\nHerceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.\nHerceptin should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result. Accurate and validated assay methods should be used (see sections 4.4 and 5.1).\nHerceptin is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):\nHerceptin is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC).","extracted":true,"target":{"targets":["HER2"],"modality":"monoclonal antibody","label":"HER2-directed monoclonal antibody","mechanism":"Binds subdomain IV of HER2, inhibiting ligand-independent signalling, preventing extracellular domain cleavage, and mediating antibody-dependent cell-mediated cytotoxicity.","quote":"Trastuzumab binds with high affinity and specificity to sub-domain IV, a juxta-membrane region of HER2’s extracellular domain.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf"},"copies":[{"brand":"Kanjinti","company":"Amgen Europe B.V.","kind":"biosimilar","authorised":"2018-05-16","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/kanjinti"},{"brand":"Ontruzant","company":"Samsung Bioepis NL B.V.","kind":"biosimilar","authorised":"2017-11-15","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ontruzant"},{"brand":"Zercepac","company":"Accord Healthcare S.L.U.","kind":"biosimilar","authorised":"2020-07-27","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zercepac"},{"brand":"Herzuma","company":"Celltrion Healthcare Hungary Kft.","kind":"biosimilar","authorised":"2018-02-09","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/herzuma"},{"brand":"Herwenda","company":"Sandoz GmbH","kind":"biosimilar","authorised":"2023-11-15","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/herwenda"},{"brand":"Trazimera","company":"Pfizer Europe MA EEIG","kind":"biosimilar","authorised":"2018-07-26","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/trazimera"},{"brand":"Dazublys","company":"CuraTeQ Biologics (Malta) Limited","kind":"biosimilar","authorised":"2025-06-30","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/dazublys"},{"brand":"Ogivri","company":"Biosimilar Collaborations Ireland Limited","kind":"biosimilar","authorised":"2018-12-12","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ogivri"}]},{"key":"trastuzumab-deruxtecan__enhertu","inn":"trastuzumab deruxtecan","brand":"Enhertu","company":"Daiichi Sankyo Europe GmbH","ema_product_number":"EMEA/H/C/005124","atc_code":"L01FD04","authorised":"2021-01-18","pi_updated":"2026-10-20","conditional":true,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/enhertu","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/enhertu-epar-product-information_de.pdf","indication_text":"Breast cancer\nHER2-positive breast cancer\nEnhertu in combination with pertuzumab is indicated for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer (for biomarker-based patient selection, see section 4.2).\nEnhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.\nHER2-low and HER2-ultralow breast cancer\nEnhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic\n• hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment (see sections 4.2 and 5.1).\n• HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4.2).\nNon-small cell lung cancer (NSCLC)\nEnhertu as monotherapy is indicated for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.\nGastric cancer\nEnhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.\nOther unresectable or metastatic solid tumours\nEnhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who have no satisfactory treatment options (see sections 4.4 and 5.1; for biomarker-based patient selection, see section 4.2).","extracted":true,"target":{"targets":["HER2"],"modality":"antibody-drug conjugate","label":"HER2-directed antibody-drug conjugate","mechanism":"Binds to HER2 on tumour cells, internalises, and releases a topoisomerase I inhibitor payload that induces DNA damage and apoptotic cell death.","quote":"Enhertu, trastuzumab deruxtecan, is a HER2-targeted antibody-drug conjugate.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf"},"copies":[]},{"key":"degarelix__firmagon","inn":"degarelix","brand":"Firmagon","company":"Ferring Pharmaceuticals A/S","ema_product_number":"EMEA/H/C/000986","atc_code":"L02BX02","authorised":"2009-02-17","pi_updated":"2022-03-30","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/firmagon","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/firmagon-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/firmagon-epar-product-information_de.pdf","indication_text":"FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated:\n- for treatment of adult male patients with advanced hormone-dependent prostate cancer.\n- for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.\n- as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.","extracted":true,"target":{"targets":["GnRH receptor"],"modality":"protein or peptide","label":"GnRH receptor antagonist","mechanism":"Competitively and reversibly binds pituitary GnRH receptors, rapidly reducing LH and FSH release and thereby testicular testosterone secretion, without an initial testosterone surge.","quote":"Degarelix is a selective gonadotrophin releasing-hormone (GnRH) antagonist that competitively and reversibly binds to the pituitary GnRH receptors, thereby rapidly reducing the release of the gonadotrophins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), and thereby reducing the secretion of testosterone (T) by the testes.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/firmagon-epar-product-information_en.pdf"},"copies":[{"brand":"Degarelix Accord","company":"Accord Healthcare S.L.U.","kind":"generic","authorised":"2023-09-29","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/degarelix-accord"}]},{"key":"polatuzumab-vedotin__polivy","inn":"polatuzumab vedotin","brand":"Polivy","company":"Roche Registration GmbH","ema_product_number":"EMEA/H/C/004870","atc_code":"L01FX14","authorised":"2020-01-16","pi_updated":"2026-10-20","conditional":false,"exceptional":false,"orphan":true,"prime":true,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/polivy","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/polivy-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/polivy-epar-product-information_de.pdf","indication_text":"Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).\nPolivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant.","extracted":true,"target":{"targets":["CD79b"],"modality":"antibody-drug conjugate","label":"CD79b-directed antibody-drug conjugate","mechanism":"Binds CD79b on B-cells, undergoes internalisation, and releases MMAE to disrupt microtubules, inhibiting cell division and inducing apoptosis.","quote":"The monoclonal antibody binds with high affinity and selectivity to CD79b, a cell surface component of the B-cell receptor.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/polivy-epar-product-information_en.pdf"},"copies":[]},{"key":"radium-ra223-dichloride__xofigo","inn":"radium Ra223 dichloride","brand":"Xofigo","company":"Bayer AG","ema_product_number":"EMEA/H/C/002653","atc_code":"V10XX03","authorised":"2013-11-13","pi_updated":"2026-07-30","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/xofigo","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/xofigo-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/xofigo-epar-product-information_de.pdf","indication_text":"Xofigo monotherapy or in combination with luteinising hormone releasing hormone (LHRH) analogue is indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), symptomatic bone metastases and no known visceral metastases, in progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment (see section 4.4).","extracted":true,"target":{"targets":["hydroxyapatite"],"modality":"radioligand","label":"Alpha particle-emitting radiopharmaceutical","mechanism":"Mimics calcium to form complexes with hydroxyapatite in bone metastases, emitting high linear energy transfer alpha particles that cause lethal double-strand DNA breaks in adjacent tumor cells.","quote":"Its active moiety radium-223 (as radium-223 dichloride) mimics calcium and selectively targets bone, specifically areas of bone metastases, by forming complexes with the bone mineral hydroxyapatite.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/xofigo-epar-product-information_en.pdf"},"copies":[]},{"key":"enzalutamide__xtandi","inn":"enzalutamide","brand":"Xtandi","company":"Astellas Pharma Europe B.V.","ema_product_number":"EMEA/H/C/002639","atc_code":"L02BB04","authorised":"2013-06-21","pi_updated":"2026-07-29","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/xtandi","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/xtandi-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/xtandi-epar-product-information_de.pdf","indication_text":"Xtandi is indicated:\n• as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 5.1).\n• in combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1).\n• for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).\n• for the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1).\n• for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.","extracted":true,"target":{"targets":["androgen receptor"],"modality":"small molecule","label":"Androgen receptor signalling inhibitor","mechanism":"Competitively blocks androgen binding to the androgen receptor, inhibiting receptor nuclear translocation and DNA association, decreasing prostate cancer cell growth; no agonist activity.","quote":"Enzalutamide is a potent androgen receptor signalling inhibitor that blocks several steps in the androgen receptor signalling pathway.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/xtandi-epar-product-information_en.pdf"},"copies":[{"brand":"Enzalutamide Viatris","company":"Viatris Limited","kind":"generic","authorised":"2024-08-22","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/enzalutamide-viatris"},{"brand":"Enzalutamide Accordpharma","company":"Accord Healthcare","kind":"generic","authorised":"","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/enzalutamide-accordpharma"}]},{"key":"mogamulizumab__poteligeo","inn":"mogamulizumab","brand":"Poteligeo","company":"Kyowa Kirin Holdings B.V.","ema_product_number":"EMEA/H/C/004232","atc_code":"L01XC25","authorised":"2018-11-22","pi_updated":"2026-10-20","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/poteligeo","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/poteligeo-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/poteligeo-epar-product-information_de.pdf","indication_text":"POTELIGEO is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.","extracted":true,"target":{"targets":["CCR4"],"modality":"monoclonal antibody","label":"CCR4-directed monoclonal antibody","mechanism":"Selectively binds to CCR4 on lymphocytes and T-cell malignancies, resulting in depletion of the target cells.","quote":"Mogamulizumab is a defucosylated, humanised IgG1 kappa immunoglobulin that selectively binds to CCR4, a G protein-coupled receptor for CC chemokines that is involved in the trafficking of lymphocytes to various organs including the skin, resulting in depletion of the target cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/poteligeo-epar-product-information_en.pdf"},"copies":[]},{"key":"glofitamab__columvi","inn":"glofitamab","brand":"Columvi","company":"Roche Registration GmbH ","ema_product_number":"EMEA/H/C/005751","atc_code":"L01FX28","authorised":"2023-07-07","pi_updated":"2026-10-20","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/columvi","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/columvi-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/columvi-epar-product-information_de.pdf","indication_text":"Columvi in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT).\nColumvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.","extracted":true,"target":{"targets":["CD20","CD3"],"modality":"bispecific antibody","label":"CD20 × CD3 bispecific antibody","mechanism":"Binds CD20 on B cells and CD3 on T cells to induce an immunological synapse, leading to T-cell activation and targeted lysis of CD20-expressing B cells.","quote":"Glofitamab is a bispecific monoclonal antibody that binds bivalently to CD20 expressed on the surface of B cells and monovalently to CD3 in the T-cell receptor complex expressed on the surface of T cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/columvi-epar-product-information_en.pdf"},"copies":[]},{"key":"everolimus__afinitor","inn":"everolimus","brand":"Afinitor","company":"Novartis Europharm Limited","ema_product_number":"EMEA/H/C/001038","atc_code":"L01XE10","authorised":"2009-08-02","pi_updated":"2025-11-20","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/afinitor","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/afinitor-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/afinitor-epar-product-information_de.pdf","indication_text":"Hormone receptor-positive advanced breast cancer\nAfinitor is indicated for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.\nNeuroendocrine tumours of pancreatic origin\nAfinitor is indicated for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.\nNeuroendocrine tumours of gastrointestinal or lung origin\nAfinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease (see sections 4.4 and 5.1).\nRenal cell carcinoma\nAfinitor is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.","extracted":true,"target":{"targets":["mTOR"],"modality":"small molecule","label":"mTOR inhibitor","mechanism":"Binds to intracellular FKBP-12 to form a complex that inhibits mTORC1 activity, reducing protein synthesis, cell cycle progression, and angiogenesis.","quote":"Everolimus is a selective mTOR (mammalian target of rapamycin) inhibitor.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/afinitor-epar-product-information_en.pdf"},"copies":[]},{"key":"everolimus__votubia","inn":"everolimus","brand":"Votubia","company":"Novartis Europharm Limited","ema_product_number":"EMEA/H/C/002311","atc_code":"L01XE10","authorised":"2011-09-02","pi_updated":"2025-11-20","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/votubia","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/votubia-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/votubia-epar-product-information_de.pdf","indication_text":"Renal angiomyolipoma associated with tuberous sclerosis complex (TSC)\nVotubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with TSC who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery.\nThe evidence is based on analysis of change in sum of angiomyolipoma volume.\nSubependymal giant cell astrocytoma (SEGA) associated with TSC\nVotubia is indicated for the treatment of adult and paediatric patients with SEGA associated with TSC who require therapeutic intervention but are not amenable to surgery.\nThe evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease-related symptoms, has not been demonstrated.\nRefractory seizures associated with tuberous sclerosis complex (TSC)\nVotubia is indicated as adjunctive treatment of patients aged 2 years and older whose refractory partial-onset seizures, with or without secondary generalisation, are associated with TSC.","extracted":true,"target":{"targets":["mTOR"],"modality":"small molecule","label":"mTOR inhibitor","mechanism":"Everolimus binds intracellular FKBP-12 to inhibit mTORC1 activity, blocking downstream signalling that regulates protein synthesis, the cell cycle, angiogenesis, and glycolysis.","quote":"Everolimus is a selective mTOR (mammalian target of rapamycin) inhibitor.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/votubia-epar-product-information_en.pdf"},"copies":[]},{"key":"tasonermin__beromun","inn":"tasonermin","brand":"Beromun","company":"Belpharma s.a.","ema_product_number":"EMEA/H/C/000206","atc_code":"L03AX11","authorised":"1999-04-12","pi_updated":"2026-05-28","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/beromun","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/beromun-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/beromun-epar-product-information_de.pdf","indication_text":"Beromun is indicated in adults. as an adjunct to surgery for subsequent removal of the tumour so as to prevent or delay amputation, or in the palliative situation, for irresectable soft tissue sarcoma of the limbs, used in combination with melphalan via mild hyperthermic isolated limb perfusion (ILP).","extracted":true,"target":{"targets":[],"modality":"protein or peptide","label":"Recombinant tumor necrosis factor alfa","mechanism":"Tasonermin directly inhibits tumour cell proliferation, disrupts tumour vasculature leading to microvascular thrombosis, and activates immune cells to promote antitumour activity.","quote":"Tasonermin is cytotoxic or cytostatic in vitro for a variety of tumour cell lines of different histogenesis.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/beromun-epar-product-information_en.pdf"},"copies":[]},{"key":"dacomitinib__vizimpro","inn":"dacomitinib","brand":"Vizimpro","company":"Pfizer Europe MA EEIG","ema_product_number":"EMEA/H/C/004779","atc_code":"L01EB07","authorised":"2019-04-02","pi_updated":"2024-12-17","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/vizimpro","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/vizimpro-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/vizimpro-epar-product-information_de.pdf","indication_text":"Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.","extracted":true,"target":{"targets":["EGFR","HER2","HER4"],"modality":"small molecule","label":"Pan-HER kinase inhibitor","mechanism":"Dacomitinib selectively and irreversibly binds to HER family receptors (EGFR/HER1, HER2, and HER4) to provide prolonged inhibition, including against mutated EGFR.","quote":"Dacomitinib is a pan-human epidermal growth factor receptor (HER) (EGFR/HER1, HER2, and HER4) inhibitor, with activity against mutated EGFR with deletions in exon 19 or the L858R substitution in exon 21.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/vizimpro-epar-product-information_en.pdf"},"copies":[]},{"key":"gefitinib__iressa","inn":"gefitinib","brand":"Iressa","company":"AstraZeneca AB","ema_product_number":"EMEA/H/C/001016","atc_code":"L01XE02","authorised":"2009-06-24","pi_updated":"2023-07-17","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/iressa","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/iressa-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/iressa-epar-product-information_de.pdf","indication_text":"IRESSA is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (see section 4.4).","extracted":true,"target":{"targets":["EGFR"],"modality":"small molecule","label":"EGFR tyrosine kinase inhibitor","mechanism":"Gefitinib is a selective small-molecule inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase domain, inhibiting growth in tumours with sensitising EGFR mutations.","quote":"Gefitinib is a selective small molecule inhibitor of the epidermal growth factor receptor tyrosine kinase and is an effective treatment for patients with tumours with activating mutations of the EGFR tyrosine kinase domain regardless of line of therapy.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/iressa-epar-product-information_en.pdf"},"copies":[]},{"key":"enfortumab-vedotin__padcev","inn":"enfortumab vedotin","brand":"Padcev","company":"Astellas Pharma Europe B.V.","ema_product_number":"EMEA/H/C/005392","atc_code":"L01FX13","authorised":"2022-04-13","pi_updated":"2026-10-16","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/padcev","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/padcev-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/padcev-epar-product-information_de.pdf","indication_text":"Muscle invasive bladder cancer (MIBC)\nPadcev, in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with resectable muscle invasive bladder cancer (MIBC).\nUnresectable or metastatic urothelial cancer\nPadcev, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.\nLocally advanced or metastatic urothelial cancer\nPadcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor (see section 5.1).","extracted":true,"target":{"targets":["Nectin-4"],"modality":"antibody-drug conjugate","label":"Nectin-4-directed antibody-drug conjugate","mechanism":"Binds Nectin-4 on cancer cells, internalises, and releases MMAE to disrupt microtubules, causing cell cycle arrest and apoptosis.","quote":"Enfortumab vedotin is an ADC targeting Nectin-4, an adhesion protein located on the surface of the urothelial cancer cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/padcev-epar-product-information_en.pdf"},"copies":[]},{"key":"gemtuzumab-ozogamicin__mylotarg","inn":"gemtuzumab ozogamicin","brand":"Mylotarg","company":"Pfizer Europe MA EEIG","ema_product_number":"EMEA/H/C/004204","atc_code":"","authorised":"2018-04-19","pi_updated":"2025-09-17","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/mylotarg","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/mylotarg-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/mylotarg-epar-product-information_de.pdf","indication_text":"MYLOTARG is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients aged 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL) (see sections 4.4 and 5.1).","extracted":true,"target":{"targets":["CD33"],"modality":"antibody-drug conjugate","label":"CD33-directed antibody-drug conjugate","mechanism":"It binds CD33-expressing cells, internalises, and releases calicheamicin to induce double-stranded DNA breaks and apoptotic cell death.","quote":"Gemtuzumab ozogamicin is a CD33-directed ADC.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/mylotarg-epar-product-information_en.pdf"},"copies":[]},{"key":"cabozantinib__cabometyx","inn":"cabozantinib","brand":"Cabometyx","company":"Ipsen Pharma","ema_product_number":"EMEA/H/C/004163","atc_code":"L01EX07","authorised":"2016-09-09","pi_updated":"2026-10-15","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/cabometyx","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/cabometyx-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/cabometyx-epar-product-information_de.pdf","indication_text":"Renal cell carcinoma (RCC)\nCABOMETYX is indicated as monotherapy for advanced renal cell carcinoma\n- as first-line treatment of adult patients with intermediate or poor risk (see section 5.1),\n- in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy (see section 5.1).\nCABOMETYX, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1).\nHepatocellular carcinoma (HCC)\nCABOMETYX is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.\nDifferentiated thyroid carcinoma (DTC)\nCABOMETYX is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.\nNeuroendocrine Tumours (NET)\nCABOMETYX is indicated for the treatment of adult patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues.","extracted":true,"target":{"targets":["MET","VEGFR","AXL","RET","ROS1","TYRO3"],"modality":"small molecule","label":"Multikinase inhibitor (MET, VEGFR, AXL, RET)","mechanism":"Small-molecule inhibitor of multiple receptor tyrosine kinases, chiefly MET and VEGF receptors, plus AXL, RET, ROS1 and others, blocking tumour growth, angiogenesis and metastatic progression.","quote":"Cabozantinib was evaluated for its inhibitory activity against a variety of kinases and was identified as an inhibitor of MET (hepatocyte growth factor receptor protein) and VEGF (vascular endothelial growth factor) receptors.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/cabometyx-epar-product-information_en.pdf"},"copies":[]},{"key":"cabozantinib__cometriq","inn":"cabozantinib","brand":"Cometriq","company":"Ipsen Pharma","ema_product_number":"EMEA/H/C/002640","atc_code":"L01XE","authorised":"2014-03-21","pi_updated":"2026-10-13","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/cometriq","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/cometriq-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/cometriq-epar-product-information_de.pdf","indication_text":"COMETRIQ is indicated for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.\nFor patients in whom rearranged during transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision (see important information in section 5.1).","extracted":true,"target":{"targets":["MET","VEGFR","RET","AXL","KIT","FLT3"],"modality":"small molecule","label":"Multikinase inhibitor (MET, VEGFR, RET)","mechanism":"Small molecule that inhibits multiple receptor tyrosine kinases, primarily MET and VEGF receptors, as well as RET, AXL, KIT, and FLT3.","quote":"Cabozantinib was evaluated for its inhibitory activity against a variety of kinases and was identified as an inhibitor of MET (hepatocyte growth factor receptor protein) and VEGF (vascular endothelial growth factor) receptors.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/cometriq-epar-product-information_en.pdf"},"copies":[]},{"key":"selumetinib__koselugo","inn":"selumetinib","brand":"Koselugo","company":"AstraZeneca AB","ema_product_number":"EMEA/H/C/005244","atc_code":"L01EE04","authorised":"2021-06-17","pi_updated":"2026-10-15","conditional":true,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/koselugo","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/koselugo-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/koselugo-epar-product-information_de.pdf","indication_text":"Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult and paediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and older.\nKoselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in patients with neurofibromatosis type 1 (NF1) aged 1 year to less than 7 years and for older patients with swallowing difficulties.","extracted":true,"target":{"targets":["MEK1/2"],"modality":"small molecule","label":"Selective MEK1/2 inhibitor","mechanism":"Selumetinib selectively inhibits MEK1/2, blocking MEK activity and the RAF-MEK-ERK pathway. This can block proliferation and survival of tumour cells in which that pathway is activated.","quote":"Selumetinib is a selective inhibitor of mitogen activated protein kinase kinases 1 and 2 (MEK 1/2).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/koselugo-epar-product-information_en.pdf"},"copies":[]},{"key":"belzutifan__welireg","inn":"belzutifan","brand":"Welireg","company":"Merck Sharp & Dohme B.V.","ema_product_number":"EMEA/H/C/005636","atc_code":"L01XX74","authorised":"2025-02-12","pi_updated":"2026-10-14","conditional":true,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/welireg","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/welireg-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/welireg-epar-product-information_de.pdf","indication_text":"Renal cell carcinoma (RCC)\nWELIREG is indicated as monotherapy for the treatment of adult patients with advanced clear cell renal cell carcinoma that progressed following two or more lines of therapy that included a PD-(L)1 inhibitor and at least two VEGF-targeted therapies. von Hippel-Lindau (VHL) disease-associated tumours WELIREG is indicated as monotherapy for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated, localised renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable.","extracted":true,"target":{"targets":["HIF-2α"],"modality":"small molecule","label":"HIF-2α inhibitor","mechanism":"Belzutifan binds HIF-2α and blocks its interaction with HIF-1β, reducing transcription and expression of HIF-2α target genes linked to proliferation, angiogenesis and tumour growth.","quote":"Belzutifan is an inhibitor of the transcription factor hypoxia-inducible factor 2 alpha (HIF-2α).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/welireg-epar-product-information_en.pdf"},"copies":[]},{"key":"pertuzumab__perjeta","inn":"pertuzumab","brand":"Perjeta","company":"Roche Registration GmbH ","ema_product_number":"EMEA/H/C/002547","atc_code":"L01FD02","authorised":"2013-03-04","pi_updated":"2026-04-28","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/perjeta","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/perjeta-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/perjeta-epar-product-information_de.pdf","indication_text":"Early breast cancer\nPerjeta is indicated for use in combination with trastuzumab and chemotherapy in:\n• the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence (see section 5.1)\n• the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1) Metastatic breast cancer Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.","extracted":true,"target":{"targets":["HER2"],"modality":"monoclonal antibody","label":"HER2-targeted monoclonal antibody","mechanism":"Pertuzumab binds the dimerization domain of HER2, blocking heterodimerisation with other HER family receptors to inhibit downstream MAP kinase and PI3K signalling, while also mediating ADCC.","quote":"Pertuzumab is a recombinant humanised monoclonal antibody that specifically targets the extracellular dimerization domain (subdomain II) of the human epidermal growth factor receptor 2 protein (HER2), and thereby, blocks ligand-dependent heterodimerisation of HER2 with other HER family members, including EGFR, HER3 and HER4.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/perjeta-epar-product-information_en.pdf"},"copies":[{"brand":"Poherdy","company":"Organon N.V.","kind":"biosimilar","authorised":"2026-04-23","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/poherdy"}]},{"key":"dostarlimab__jemperli","inn":"dostarlimab","brand":"Jemperli","company":"GlaxoSmithKline Trading Services Limited","ema_product_number":"EMEA/H/C/005204","atc_code":"L01FF07","authorised":"2021-04-21","pi_updated":"2026-10-13","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/jemperli","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/jemperli-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/jemperli-epar-product-information_de.pdf","indication_text":"JEMPERLI is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy.\nJEMPERLI is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability-high (MSI-H) recurrent or advanced EC that has progressed on or following prior treatment with a platinum-containing regimen.","extracted":true,"target":{"targets":["PD-1"],"modality":"monoclonal antibody","label":"PD-1 inhibitor (antibody)","mechanism":"Dostarlimab binds to PD-1 receptors and blocks interaction with PD-L1 and PD-L2, reactivating and potentiating anti-tumour T-cell responses.","quote":"Dostarlimab is a humanised mAb of the IgG4 isotype that binds to PD-1 receptors and blocks the interactions of binding with its ligands PD-L1 and PD-L2.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/jemperli-epar-product-information_en.pdf"},"copies":[]},{"key":"durvalumab__imfinzi","inn":"durvalumab","brand":"Imfinzi","company":"AstraZeneca AB","ema_product_number":"EMEA/H/C/004771","atc_code":"L01XC28","authorised":"2018-09-21","pi_updated":"2026-05-18","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/imfinzi","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/imfinzi-epar-product-information_de.pdf","indication_text":"Non-Small Cell Lung Cancer (NSCLC)\nIMFINZI in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements (for selection criteria, see section 5.1).\nIMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (see section 5.1).\nIMFINZI in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations.\nSmall Cell Lung Cancer (SCLC)\nIMFINZI as monotherapy is indicated for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy.\nIMFINZI in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).\nBiliary Tract Cancer (BTC)\nIMFINZI in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adults with unresectable or metastatic biliary tract cancer (BTC).\nHepatocellular Carcinoma (HCC)\nIMFINZI as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).\nIMFINZI in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).\nEndometrial Cancer\nIMFINZI in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with:\n• IMFINZI as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR)\n• IMFINZI in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR).\nMuscle Invasive Bladder Cancer (MIBC)\nIMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).\nGastric or Gastro-oesophageal Junction Adenocarcinoma (GC/GEJC)\nIMFINZI in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant IMFINZI monotherapy, is indicated for the treatment of adults with resectable gastric or gastro-oesophageal junction adenocarcinoma.","extracted":true,"target":{"targets":["PD-L1"],"modality":"monoclonal antibody","label":"PD-L1 inhibitor (antibody)","mechanism":"Durvalumab selectively blocks PD-L1 interaction with PD-1 and CD80, releasing inhibition of T-cell activation and enhancing antitumour immune responses.","quote":"Durvalumab is a fully human, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that selectively blocks the interaction of PD-L1 with PD-1 and CD80 (B7.1).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf"},"copies":[]},{"key":"lazertinib__lazcluze","inn":"lazertinib","brand":"Lazcluze","company":"Janssen Cilag International NV","ema_product_number":"EMEA/H/C/006074","atc_code":"L01EB09","authorised":"2025-01-20","pi_updated":"2026-10-12","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lazcluze","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/lazcluze-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/lazcluze-epar-product-information_de.pdf","indication_text":"Lazcluze in combination with amivantamab is indicated for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations.","extracted":true,"target":{"targets":["EGFR"],"modality":"small molecule","label":"EGFR tyrosine kinase inhibitor","mechanism":"Lazertinib is an irreversible EGFR tyrosine kinase inhibitor that selectively inhibits primary activating EGFR mutations and the T790M resistance mutation.","quote":"Lazertinib is an irreversible EGFR tyrosine kinase inhibitor (TKI).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/lazcluze-epar-product-information_en.pdf"},"copies":[]},{"key":"nintedanib__ofev","inn":"nintedanib","brand":"Ofev","company":"Boehringer Ingelheim International GmbH","ema_product_number":"EMEA/H/C/003821","atc_code":"L01EX09","authorised":"2015-01-14","pi_updated":"2026-01-06","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ofev","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/ofev-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/ofev-epar-product-information_de.pdf","indication_text":"Ofev is indicated in adults for the treatment of Idiopathic Pulmonary Fibrosis (IPF).","extracted":false,"target":null,"copies":[{"brand":"Nintedanib Accord","company":"Accord Healthcare S.L.U.","kind":"generic","authorised":"2024-04-19","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/nintedanib-accord"},{"brand":"Nintedanib Viatris","company":"Viatris Limited","kind":"generic","authorised":"2025-08-22","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/nintedanib-viatris"}]},{"key":"nintedanib__vargatef","inn":"nintedanib","brand":"Vargatef","company":"Boehringer Ingelheim International GmbH","ema_product_number":"EMEA/H/C/002569","atc_code":"L01EX09","authorised":"2014-11-21","pi_updated":"2026-06-10","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/vargatef","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/vargatef-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/vargatef-epar-product-information_de.pdf","indication_text":"Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy.","extracted":true,"target":{"targets":["VEGFR1-3","PDGFRA","PDGFRB","FGFR1-3"],"modality":"small molecule","label":"Triple angiokinase inhibitor (VEGFR, PDGFR, FGFR)","mechanism":"Binds the ATP pocket of VEGFR1-3, PDGFRα/β and FGFR1-3, blocking signalling needed for endothelial and perivascular cell proliferation and survival; also inhibits FLT3, LCK and SRC.","quote":"Nintedanib is a triple angiokinase inhibitor blocking vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR α and ß) and fibroblast growth factor receptors (FGFR 1-3) kinase activity.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/vargatef-epar-product-information_en.pdf"},"copies":[{"brand":"Nintedanib Accord","company":"Accord Healthcare S.L.U.","kind":"generic","authorised":"2024-04-19","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/nintedanib-accord"},{"brand":"Nintedanib Viatris","company":"Viatris Limited","kind":"generic","authorised":"2025-08-22","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/nintedanib-viatris"}]},{"key":"sunitinib__sutent","inn":"sunitinib","brand":"Sutent","company":"Pfizer Limited","ema_product_number":"EMEA/H/C/000687","atc_code":"L01EX01","authorised":"2006-07-19","pi_updated":"2025-03-10","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/sutent","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/sutent-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/sutent-epar-product-information_de.pdf","indication_text":"Gastrointestinal stromal tumour (GIST)\nSutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance.\nMetastatic renal cell carcinoma (MRCC)\nSutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.\nPancreatic neuroendocrine tumours (pNET)\nSutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults.","extracted":true,"target":{"targets":["PDGFRA","PDGFRB","VEGFR1","VEGFR2","VEGFR3","KIT"],"modality":"small molecule","label":"Multikinase inhibitor (VEGFR, PDGFR, KIT)","mechanism":"Sunitinib inhibits multiple receptor tyrosine kinases, including PDGFR, VEGFR, KIT, and FLT3, to impair tumor growth, neoangiogenesis, and metastatic progression.","quote":"Sunitinib was identified as an inhibitor of platelet-derived growth factor receptors (PDGFRα and PDGFRβ), VEGF receptors (VEGFR1, VEGFR2, and VEGFR3), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor (CSF-1R), and the glial cell-line derived neurotrophic factor receptor (RET).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/sutent-epar-product-information_en.pdf"},"copies":[{"brand":"Sunitinib Accord","company":"Accord Healthcare S.L.U.","kind":"generic","authorised":"2021-02-11","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/sunitinib-accord"}]},{"key":"camizestrant__etcamah","inn":"camizestrant","brand":"Etcamah","company":"AstraZeneca AB ","ema_product_number":"EMEA/H/C/006494","atc_code":"L02BA05","authorised":"2026-07-20","pi_updated":"2026-07-21","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/etcamah","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/etcamah-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/etcamah-epar-product-information_de.pdf","indication_text":"Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) is indicated for the treatment of adult patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1-mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor (for biomarker based patient-selection, see section 4.2 and 5.1).\nIn pre- or peri-menopausal women and in men, Etcamah plus a CDK4/6 inhibitor should be combined with a luteinizing hormone releasing hormone (LHRH) agonist or antagonist.","extracted":true,"target":{"targets":["ERα (estrogen receptor alpha)"],"modality":"small molecule","label":"Selective estrogen receptor degrader (SERD)","mechanism":"Oral SERD that binds the ERα ligand-binding domain, antagonising wild-type and ESR1-mutant ERα and inducing its proteasome-dependent degradation without agonist activity.","quote":"Camizestrant binds to the ligand binding domain of ERα, antagonising the activity of ERα encoded by both wild-type ESR1 and mutated ESR1, and inducing proteasome-dependent degradation of ERα, without agonising ERα.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/etcamah-epar-product-information_en.pdf"},"copies":[]},{"key":"serplulimab__hetronifly","inn":"serplulimab","brand":"Hetronifly","company":"Accord Healthcare S.L.U.","ema_product_number":"EMEA/H/C/006170","atc_code":"L01FF12","authorised":"2025-02-03","pi_updated":"2026-10-08","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/hetronifly","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/hetronifly-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/hetronifly-epar-product-information_de.pdf","indication_text":"Small cell lung cancer (SCLC)\nHETRONIFLY in combination with carboplatin and etoposide is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).\nNon-small cell lung carcinoma (NSCLC)\nHETRONIFLY in combination with carboplatin and pemetrexed is indicated for the first-line treatment of adult non-squamous NSCLC patients with no EGFR, ALK or ROS1 positive mutations and who have:\n locally advanced NSCLC who are not candidates for surgery or radiotherapy, or  metastatic NSCLC.\nHETRONIFLY in combination with carboplatin and nab-paclitaxel is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma.\nOesophageal squamous cell carcinoma (OSCC)\nHETRONIFLY in combination with fluoropyrimidine- and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 with a CPS ≥ 5.","extracted":true,"target":{"targets":["PD-1"],"modality":"monoclonal antibody","label":"PD-1 inhibitor (antibody)","mechanism":"Serplulimab binds PD-1 and blocks its interaction with PD-L1 and PD-L2, potentiating T-cell and anti-tumour responses.","quote":"Serplulimab (HLX10) is a humanised monoclonal IgG4 antibody, which binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with ligands PD-L1 and PD-L2.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/hetronifly-epar-product-information_en.pdf"},"copies":[]},{"key":"bevacizumab__avastin","inn":"bevacizumab","brand":"Avastin","company":"Roche Registration GmbH","ema_product_number":"EMEA/H/C/000582","atc_code":"L01FG01","authorised":"2005-01-12","pi_updated":"2026-01-27","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/avastin","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/avastin-epar-product-information_de.pdf","indication_text":"Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.\nBevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1.\nBevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avastin in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1.\nBevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.\nBevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1).\nBevacizumab in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.\nBevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. (See section 5.1).\nBevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.\nBevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents (see section 5.1).\nBevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).","extracted":true,"target":{"targets":["VEGF"],"modality":"monoclonal antibody","label":"Anti-VEGF monoclonal antibody","mechanism":"Bevacizumab binds to VEGF, preventing its interaction with VEGFR-1 and VEGFR-2 to regress tumour vasculature and inhibit angiogenesis.","quote":"Bevacizumab binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding of VEGF to its receptors, Flt-1 (VEGFR-1) and KDR (VEGFR-2), on the surface of endothelial cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf"},"copies":[{"brand":"Mvasi","company":"Amgen Europe B.V.","kind":"biosimilar","authorised":"2018-01-15","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/mvasi"},{"brand":"Aybintio","company":"Samsung Bioepis NL B.V.","kind":"biosimilar","authorised":"2020-08-19","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/aybintio"},{"brand":"Abevmy","company":"Biosimilar Collaborations Ireland Limited","kind":"biosimilar","authorised":"2021-04-21","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/abevmy"},{"brand":"Zirabev","company":"Pfizer Europe MA EEIG","kind":"biosimilar","authorised":"2019-02-14","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zirabev"},{"brand":"Alymsys","company":"Mabxience Research SL","kind":"biosimilar","authorised":"2021-03-26","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/alymsys"},{"brand":"Avzivi","company":"FGK Representative Service GmbH","kind":"biosimilar","authorised":"2024-07-26","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/avzivi"},{"brand":"Vegzelma","company":"Celltrion Healthcare Hungary Kft.","kind":"biosimilar","authorised":"2022-08-17","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/vegzelma"},{"brand":"Oyavas","company":"STADA Arzneimittel AG","kind":"biosimilar","authorised":"2021-03-26","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/oyavas"}]},{"key":"tepotinib__tepmetko","inn":"tepotinib","brand":"Tepmetko","company":"Merck Europe B.V.","ema_product_number":"EMEA/H/C/005524","atc_code":"L01EX21","authorised":"2022-02-16","pi_updated":"2026-10-08","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tepmetko","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/tepmetko-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/tepmetko-epar-product-information_de.pdf","indication_text":"TEPMETKO as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.","extracted":true,"target":{"targets":["MET"],"modality":"small molecule","label":"MET inhibitor","mechanism":"A reversible ATP-competitive small molecule inhibitor that blocks MET phosphorylation and downstream PI3K/Akt and MAPK/ERK signalling.","quote":"Tepotinib is a reversible Type I adenosine triphosphate (ATP)-competitive small molecule inhibitor of MET.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/tepmetko-epar-product-information_en.pdf"},"copies":[]},{"key":"ibrutinib__imbruvica","inn":"ibrutinib","brand":"Imbruvica","company":"Janssen-Cilag International NV","ema_product_number":"EMEA/H/C/003791","atc_code":"L01EL01","authorised":"2014-10-21","pi_updated":"2026-10-07","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/imbruvica","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/imbruvica-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/imbruvica-epar-product-information_de.pdf","indication_text":"IMBRUVICA in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (IMBRUVICA + R-CHOP) alternating with R-DHAP (or R-DHAOx) without IMBRUVICA, followed by IMBRUVICA monotherapy, is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplantation (ASCT).\nIMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory MCL.\nIMBRUVICA as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).\nIMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.\nIMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM.","extracted":true,"target":{"targets":["BTK"],"modality":"small molecule","label":"BTK inhibitor","mechanism":"Covalently binds to the active site of Bruton's tyrosine kinase (BTK) to sustain enzymatic inhibition, blocking B-cell receptor signalling and inhibiting malignant B-cell proliferation and survival.","quote":"Ibrutinib is a potent, small-molecule inhibitor of Bruton’s tyrosine kinase (BTK).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/imbruvica-epar-product-information_en.pdf"},"copies":[]},{"key":"mosunetuzumab__lunsumio","inn":"mosunetuzumab","brand":"Lunsumio","company":"Roche Registration GmbH","ema_product_number":"EMEA/H/C/005680","atc_code":"L01FX25","authorised":"2022-06-03","pi_updated":"2026-10-07","conditional":true,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lunsumio","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/lunsumio-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/lunsumio-epar-product-information_de.pdf","indication_text":"Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.","extracted":true,"target":{"targets":["CD20","CD3"],"modality":"bispecific antibody","label":"CD20 × CD3 bispecific antibody","mechanism":"Simultaneously engages CD20 on B-cells and CD3 on T-cells, forming an immunological synapse that activates T-cells to induce B-cell lysis via perforin and granzymes.","quote":"Mosunetuzumab is an anti-CD20/CD3 T-cell engaging bispecific antibody targeting CD20-expressing B-cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/lunsumio-epar-product-information_en.pdf"},"copies":[]},{"key":"acalabrutinib__calquence","inn":"acalabrutinib","brand":"Calquence","company":"AstraZeneca AB","ema_product_number":"EMEA/H/C/005299","atc_code":"L01EL02","authorised":"2020-11-05","pi_updated":"2026-10-07","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/calquence","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/calquence-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/calquence-epar-product-information_de.pdf","indication_text":"Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).\nCalquence in combination with venetoclax with or without obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).\nCalquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.\nCalquence in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant (ASCT).\nCalquence as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) not previously treated with a BTK inhibitor.","extracted":true,"target":{"targets":["BTK"],"modality":"small molecule","label":"Selective BTK inhibitor","mechanism":"Acalabrutinib covalently binds to the active site of Bruton tyrosine kinase (BTK), irreversibly inactivating it to block B-cell survival, proliferation, and trafficking.","quote":"Acalabrutinib is a selective inhibitor of Bruton tyrosine kinase (BTK).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/calquence-epar-product-information_en.pdf"},"copies":[]},{"key":"ropeginterferon-alfa-2b__besremi","inn":"ropeginterferon alfa-2b","brand":"Besremi","company":"AOP Orphan Pharmaceuticals GmbH","ema_product_number":"EMEA/H/C/004128","atc_code":"L03AB15","authorised":"2019-02-15","pi_updated":"2026-04-24","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/besremi","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/besremi-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/besremi-epar-product-information_de.pdf","indication_text":"Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.","extracted":true,"target":{"targets":["IFNAR"],"modality":"protein or peptide","label":"Interferon alfa receptor agonist","mechanism":"Binds to the interferon alfa receptor (IFNAR), activating downstream JAK/STAT signaling to inhibit proliferation of hematopoietic progenitor cells and reduce JAK2V617F allele burden.","quote":"Interferon alfa belongs to the class of type I interferons which exhibit their cellular effects by binding to a transmembrane receptor termed interferon alfa receptor (IFNAR).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/besremi-epar-product-information_en.pdf"},"copies":[]},{"key":"rituximab__mabthera","inn":"rituximab","brand":"MabThera","company":"Roche Registration GmbH","ema_product_number":"EMEA/H/C/000165","atc_code":"L01XC02","authorised":"1998-06-02","pi_updated":"2026-08-06","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/mabthera","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/mabthera-epar-product-information_de.pdf","indication_text":"Non-Hodgkin’s lymphoma (NHL)\nMabThera is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma in combination with chemotherapy.\nMabThera maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy.\nMabThera monotherapy is indicated for treatment of adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.\nMabThera is indicated for the treatment of adult patients with CD20 positive diffuse large B-cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.\nMabThera in combination with chemotherapy is indicated for the treatment of paediatric patients (aged 6 months to less than 18 years old) with previously untreated advanced stage CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL).\nChronic lymphocytic leukaemia (CLL)\nMabThera in combination with chemotherapy is indicated for the treatment of adult patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including MabThera or patients refractory to previous MabThera plus chemotherapy.\nSee section 5.1 for further information.\nRheumatoid arthritis\nMabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.\nMabThera has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.\nGranulomatosis with polyangiitis and microscopic polyangiitis\nMabThera, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).\nMabThera, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged 2 to less than 18 years old) with severe, active GPA (Wegener’s) and MPA.\nPemphigus vulgaris\nMabThera is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris (PV).\nMabThera is indicated in adults for non-Hodgkin’s lymphoma (NHL):\nMabThera is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.\nMabThera maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.\nMabThera is indicated for the treatment of patients with CD20 positive diffuse large B-cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.\nMabThera is indicated in adults in combination with chemotherapy for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia (CLL). Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including MabThera or patients refractory to previous MabThera plus chemotherapy.","extracted":true,"target":{"targets":["CD20"],"modality":"monoclonal antibody","label":"Anti-CD20 monoclonal antibody","mechanism":"Binds specifically to CD20 on B lymphocytes, recruiting immune effector functions to mediate B-cell lysis via CDC, ADCC, and induction of apoptosis.","quote":"Rituximab binds specifically to the transmembrane antigen, CD20, a non-glycosylated phosphoprotein, located on pre-B and mature B lymphocytes.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf"},"copies":[{"brand":"Ruxience","company":"Pfizer Europe MA EEIG","kind":"biosimilar","authorised":"2020-04-01","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ruxience"},{"brand":"Riximyo","company":"Sandoz GmbH","kind":"biosimilar","authorised":"2017-06-15","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/riximyo"},{"brand":"Rixathon","company":"Sandoz GmbH","kind":"biosimilar","authorised":"2017-06-15","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/rixathon"},{"brand":"Truxima","company":"Celltrion Healthcare Hungary Kft.","kind":"biosimilar","authorised":"2017-02-17","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/truxima"},{"brand":"Blitzima","company":"Celltrion Healthcare Hungary Kft.","kind":"biosimilar","authorised":"2017-07-13","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/blitzima"},{"brand":"Ituxredi","company":"Reddy Holding GmbH","kind":"biosimilar","authorised":"2024-09-19","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ituxredi"}]},{"key":"relatlimab-nivolumab__opdualag","inn":"relatlimab;nivolumab","brand":"Opdualag","company":"Bristol-Myers Squibb Pharma EEIG","ema_product_number":"EMEA/H/C/005481","atc_code":"L01FY02","authorised":"2022-09-15","pi_updated":"2026-07-21","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/opdualag","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/opdualag-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/opdualag-epar-product-information_de.pdf","indication_text":"Opdualag is indicated for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD-L1 expression < 1%.","extracted":true,"target":{"targets":["PD-1","LAG-3"],"modality":"monoclonal antibody","label":"PD-1 and LAG-3 checkpoint inhibitor combination","mechanism":"Binds PD-1 and LAG-3 receptors to block interaction with their ligands, reducing inhibitory signalling and enhancing T-cell activation and anti-tumour immune responses.","quote":"Opdualag is a fixed-dose combination (FDC) of nivolumab, a programmed death-1 inhibitor (anti-PD-1) and relatlimab, a lymphocyte-activation gene-3 inhibitor (anti-LAG-3).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/opdualag-epar-product-information_en.pdf"},"copies":[]},{"key":"relugolix__orgovyx","inn":"relugolix","brand":"Orgovyx","company":"Accord Healthcare S.L.U.","ema_product_number":"EMEA/H/C/005353","atc_code":"L02BX","authorised":"2022-04-29","pi_updated":"2026-10-02","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/orgovyx","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/orgovyx-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/orgovyx-epar-product-information_de.pdf","indication_text":"Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.","extracted":true,"target":{"targets":["GnRH receptor"],"modality":"small molecule","label":"GnRH receptor antagonist","mechanism":"Competitively binds pituitary GnRH receptors, blocking GnRH signalling so LH and FSH fall and testosterone is suppressed, without the initial flare seen with GnRH analogues.","quote":"Relugolix is a nonpeptide GnRH receptor antagonist that competitively binds to GnRH receptors in the anterior pituitary gland preventing native GnRH from binding and signalling the secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/orgovyx-epar-product-information_en.pdf"},"copies":[]},{"key":"arsenic-trioxide__trisenox","inn":"arsenic trioxide","brand":"Trisenox","company":"Teva B.V.","ema_product_number":"EMEA/H/C/000388","atc_code":"L01XX27","authorised":"2002-03-05","pi_updated":"2026-01-30","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/trisenox","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/trisenox-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/trisenox-epar-product-information_de.pdf","indication_text":"TRISENOX is indicated for induction of remission, and consolidation in adult patients with:\n• Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 103/μl) in combination with all-trans-retinoic acid (ATRA)\n• Relapsed/refractory acute promyelocytic leukaemia (APL) (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.\nThe response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.","extracted":true,"target":{"targets":["PML-RARA"],"modality":"small molecule","label":"PML-RARA degrader","mechanism":"Arsenic trioxide causes apoptosis with DNA fragmentation and induces damage or degradation of the PML/RAR alpha fusion protein.","quote":"Arsenic trioxide also causes damage or degradation of the fusion protein promyelocytic leukaemia/retinoic acid receptor-alpha (PML/RAR alpha).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/trisenox-epar-product-information_en.pdf"},"copies":[{"brand":"Arsenic trioxide Accord","company":"Accord Healthcare S.L.U.","kind":"generic","authorised":"2019-11-14","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/arsenic-trioxide-accord"},{"brand":"Arsenic trioxide medac","company":"medac Gesellschaft für klinische Spezialpräparate mbH","kind":"generic","authorised":"2020-09-17","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/arsenic-trioxide-medac"}]},{"key":"odronextamab__ordspono","inn":"odronextamab","brand":"Ordspono","company":"Regeneron Ireland Designated Activity Company (DAC)","ema_product_number":"EMEA/H/C/006215","atc_code":"Not yet assigned","authorised":"2024-08-22","pi_updated":"2026-10-02","conditional":true,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ordspono","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/ordspono-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/ordspono-epar-product-information_de.pdf","indication_text":"Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after two or more lines of systemic therapy.\nOrdspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) after two or more lines of systemic therapy.","extracted":true,"target":{"targets":["CD20","CD3"],"modality":"bispecific antibody","label":"CD20 × CD3 bispecific antibody","mechanism":"Odronextamab binds CD20 on B cells and CD3 on T cells, creating an immune synapse that induces T-cell activation and redirected lysis of CD20-expressing cells.","quote":"Odronextamab is a human IgG4-based bispecific antibody that binds to CD20, a B-cell surface antigen present on normal and malignant B cells and CD3, a T-cell antigen associated with the T-cell receptor complex.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/ordspono-epar-product-information_en.pdf"},"copies":[]},{"key":"dasatinib-anhydrous-__sprycel","inn":"dasatinib (anhydrous)","brand":"Sprycel","company":"Bristol-Myers Squibb Pharma EEIG","ema_product_number":"EMEA/H/C/000709","atc_code":"L01EA02","authorised":"2006-11-20","pi_updated":"2026-10-02","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/sprycel","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/sprycel-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/sprycel-epar-product-information_de.pdf","indication_text":"SPRYCEL is indicated for the treatment of adult patients with:\n▪ newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase.\n▪ chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib.\n▪ Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.\nSPRYCEL is indicated for the treatment of paediatric patients with:\n▪ newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.\n▪ newly diagnosed Ph+ ALL in combination with chemotherapy.\n▪ newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.\n▪ newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) in combination with chemotherapy.","extracted":true,"target":{"targets":["BCR-ABL","SRC","LYN","HCK"],"modality":"small molecule","label":"BCR-ABL and SRC kinase inhibitor","mechanism":"Dasatinib inhibits BCR-ABL and SRC family kinases at subnanomolar concentrations, overcoming imatinib resistance and inhibiting leukaemic disease progression.","quote":"Additionally, dasatinib inhibits SRC family kinases at subnanomolar concentrations.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/sprycel-epar-product-information_en.pdf"},"copies":[]},{"key":"tabelecleucel__ebvallo","inn":"tabelecleucel","brand":"Ebvallo","company":"Pierre Fabre Medicament","ema_product_number":"EMEA/H/C/004577","atc_code":"","authorised":"2022-12-16","pi_updated":"2026-10-02","conditional":false,"exceptional":true,"orphan":true,"prime":true,"advanced_therapy":true,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ebvallo","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/ebvallo-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/ebvallo-epar-product-information_de.pdf","indication_text":"Ebvallo is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.","extracted":true,"target":{"targets":["EBV peptide–HLA complex"],"modality":"cell therapy","label":"Allogeneic EBV-specific T-cell immunotherapy","mechanism":"Allogeneic T cells whose receptors recognise EBV peptides presented by specific HLA molecules on target cells, killing EBV-infected cells in an HLA-restricted manner.","quote":"The T-cell receptor of each clonal population within Ebvallo recognises an EBV peptide in complex with a specific HLA molecule on the surface of target cells (the restricting HLA allele) and allows the medicinal product to exert cytotoxic activity against the EBV-infected cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/ebvallo-epar-product-information_en.pdf"},"copies":[]},{"key":"pomalidomide__imnovid-previously-pomalidomide-celgene-","inn":"pomalidomide","brand":"Imnovid (previously Pomalidomide Celgene)","company":"Bristol-Myers Squibb Pharma EEIG","ema_product_number":"EMEA/H/C/002682","atc_code":"L04AX06","authorised":"2013-08-05","pi_updated":"2025-10-06","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/imnovid","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/imnovid-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/imnovid-epar-product-information_de.pdf","indication_text":"Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.\nImnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.","extracted":true,"target":{"targets":["CRBN","IKZF1","IKZF3"],"modality":"small molecule","label":"Immunomodulatory agent","mechanism":"Pomalidomide binds cereblon to recruit and degrade substrate proteins Aiolos and Ikaros, causing direct myeloma cell apoptosis, anti-angiogenic effects, and immune activation.","quote":"Pomalidomide binds directly to the protein cereblon (CRBN), which is part of an E3 ligase complex that includes deoxyribonucleic acid (DNA) damage-binding protein 1(DDB1), cullin 4 (CUL4), and regulator of cullins-1 (Roc1), and can inhibit the auto-ubiquitination of CRBN within the complex.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/imnovid-epar-product-information_en.pdf"},"copies":[{"brand":"Pomalidomide Teva","company":"Teva GmbH","kind":"generic","authorised":"2024-11-14","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/pomalidomide-teva"},{"brand":"Pomalidomide Krka","company":"Krka, d.d., Novo mesto ","kind":"generic","authorised":"2024-07-24","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/pomalidomide-krka"},{"brand":"Pomalidomide Accord","company":"Accord Healthcare S.L.U.","kind":"generic","authorised":"2024-07-26","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/pomalidomide-accord"},{"brand":"Pomalidomide Zentiva","company":"Zentiva k.s.","kind":"generic","authorised":"2024-07-24","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/pomalidomide-zentiva"},{"brand":"Pomalidomide Viatris","company":"Viatris Limited","kind":"generic","authorised":"2024-02-16","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/pomalidomide-viatris"}]},{"key":"datopotamab-deruxtecan__datroway","inn":"datopotamab deruxtecan","brand":"Datroway","company":"Daiichi Sankyo Europe GmbH","ema_product_number":"EMEA/H/C/006547","atc_code":"L01FX35","authorised":"2025-04-04","pi_updated":"2026-09-30","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/datroway","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/datroway-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/datroway-epar-product-information_de.pdf","indication_text":"Breast cancer\nDatroway as monotherapy is indicated for the first-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy (see section 5.1).\nDatroway as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting (see section 5.1).","extracted":true,"target":{"targets":["TROP2"],"modality":"antibody-drug conjugate","label":"TROP2-directed antibody-drug conjugate","mechanism":"Binds to TROP2 on tumor cells and internalises, releasing a topoisomerase I inhibitor payload that induces DNA damage and apoptotic cell death.","quote":"Datopotamab deruxtecan is a TROP2-directed antibody-drug conjugate.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/datroway-epar-product-information_en.pdf"},"copies":[]},{"key":"crizotinib__xalkori","inn":"crizotinib","brand":"Xalkori","company":"Pfizer Europe MA EEIG","ema_product_number":"EMEA/H/C/002489","atc_code":"L01ED01","authorised":"2012-10-23","pi_updated":"2025-09-17","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/xalkori","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/xalkori-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/xalkori-epar-product-information_de.pdf","indication_text":"XALKORI as monotherapy is indicated for:\n The first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)  The treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)  The treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC)  The treatment of paediatric patients (age ≥1 to <18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL)  The treatment of paediatric patients (age ≥1 to <18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK)-positive unresectable inflammatory myofibroblastic tumour (IMT)","extracted":true,"target":{"targets":["ALK","ROS1","MET","RON"],"modality":"small molecule","label":"ALK/ROS1/MET tyrosine kinase inhibitor","mechanism":"Small-molecule inhibitor of the ALK tyrosine kinase and its oncogenic fusions/mutations, and of ROS1, c-Met and RON kinases, blocking their phosphorylation to inhibit tumour growth and induce apoptosis.","quote":"Crizotinib is a selective small-molecule inhibitor of the ALK receptor tyrosine kinase (RTK) and its oncogenic variants (i.e. ALK fusion events and selected ALK mutations).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/xalkori-epar-product-information_en.pdf"},"copies":[]},{"key":"ruxolitinib-hemifumarate__ruxolitinib-viatris","inn":"ruxolitinib hemifumarate","brand":"Ruxolitinib Viatris","company":"Viatris Limited","ema_product_number":"EMEA/H/C/006618","atc_code":"L01EJ01","authorised":"2026-09-18","pi_updated":"2026-09-24","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":true,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ruxolitinib-viatris","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/ruxolitinib-viatris-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/ruxolitinib-viatris-epar-product-information_de.pdf","indication_text":"Myelofibrosis (MF)\nRuxolitinib Viatris is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.\nPolycythaemia vera (PV)\nRuxolitinib Viatris is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.\nGraft versus host disease (GvHD)\nAcute GvHD\nRuxolitinib Viatris is indicated for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).\nChronic GvHD\nRuxolitinib Viatris is indicated for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).","extracted":true,"target":{"targets":["JAK1","JAK2"],"modality":"small molecule","label":"JAK1 and JAK2 inhibitor","mechanism":"Ruxolitinib selectively inhibits the Janus Associated Kinases JAK1 and JAK2, blocking downstream JAK-STAT signalling and cell proliferation.","quote":"Ruxolitinib is a selective inhibitor of the Janus Associated Kinases (JAKs) JAK1 and JAK2 (IC50 values of 3.3 nM and 2.8 nM for JAK1 and JAK2 enzymes, respectively).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/ruxolitinib-viatris-epar-product-information_en.pdf"},"copies":[]},{"key":"tislelizumab__tevimbra","inn":"tislelizumab","brand":"Tevimbra","company":"Beone Medicines Ireland Limited","ema_product_number":"EMEA/H/C/005919","atc_code":"L01FF09","authorised":"2023-09-15","pi_updated":"2026-09-24","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tevimbra","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/tevimbra-epar-product-information_de.pdf","indication_text":"Non-small cell lung cancer (NSCLC)\nTevimbra, in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of adult patients with resectable NSCLC at high risk of recurrence (for selection criteria, see section 5.1).\nTevimbra, in combination with pemetrexed and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with non-squamous NSCLC whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have:\n• locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or\n• metastatic NSCLC.\nTevimbra, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of adult patients with squamous NSCLC who have:\n• locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or\n• metastatic NSCLC.\nTevimbra as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.\nSmall Cell Lung Cancer (SCLC)\nTevimbra, in combination with etoposide and platinum chemotherapy, is indicated for the first-line treatment of adult patients with extensive-stage SCLC.\nGastric or gastroesophageal junction (G/GEJ) adenocarcinoma\nTevimbra, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER-2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumours express PD-L1 with a tumour area positivity (TAP) score ≥ 5% (see section 5.1).\nOesophageal squamous cell carcinoma (OSCC)\nTevimbra, in combination with platinum-based chemotherapy, is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic OSCC whose tumours express PD-L1 with a TAP score ≥ 5% (see section 5.1).\nTevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic OSCC after prior platinum-based chemotherapy.\nNasopharyngeal carcinoma (NPC)\nTevimbra, in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of adult patients with recurrent, not amenable to curative surgery or radiotherapy, or metastatic NPC.","extracted":true,"target":{"targets":["PD-1"],"modality":"monoclonal antibody","label":"PD-1 inhibitor (antibody)","mechanism":"Tislelizumab binds PD-1 and blocks PD-L1 and PD-L2 binding, inhibiting negative signaling and enhancing T-cell functional activity.","quote":"Tislelizumab is a humanised immunoglobulin G4 (IgG4) variant monoclonal antibody against PD-1, binding to the extracellular domain of human PD-1.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf"},"copies":[]},{"key":"peginterferon-alfa-2a__pegasys","inn":"peginterferon alfa-2a","brand":"Pegasys","company":"pharmaand GmbH","ema_product_number":"EMEA/H/C/000395","atc_code":"L03AB11","authorised":"2002-06-20","pi_updated":"2026-09-22","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/pegasys","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/pegasys-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/pegasys-epar-product-information_de.pdf","indication_text":"Polycythaemia vera\nPegasys is indicated as monotherapy in adults for the treatment of polycythaemia vera.\nEssential thrombocythaemia\nPegasys is indicated as monotherapy in adults for the treatment of essential thrombocythaemia.\nChronic hepatitis B\nAdult patients\nPegasys is indicated for the treatment of hepatitis B envelope antigen (HBeAg)-positive or HBeAg-negative chronic hepatitis B (CHB) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (ALT) and histologically verified liver inflammation and/or fibrosis (see sections 4.4 and 5.1).\nPaediatric patients 3 years of age and older\nPegasys is indicated for the treatment of HBeAg-positive CHB in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum ALT levels. With respect to the decision to initiate treatment in paediatric patients see sections 4.2, 4.4 and 5.1.\nChronic hepatitis C\nAdult patients\nPegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis C (CHC) in patients with compensated liver disease (see sections 4.2, 4.4 and 5.1).\nFor hepatitis C virus (HCV) genotype specific activity, see sections 4.2 and 5.1.\nPaediatric patients 5 years of age and older\nPegasys in combination with ribavirin is indicated for the treatment of CHC in treatment-naïve children and adolescents 5 years of age and older who are positive for serum HCV-RNA.\nWhen deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis (see section 4.4).","extracted":true,"target":{"targets":[],"modality":"protein or peptide","label":"Pegylated interferon alfa","mechanism":"Pegylated interferon alfa-2a provides antiviral and antiproliferative activities characteristic of interferon alfa-2a.","quote":"Pegasys possesses the in vitro antiviral and antiproliferative activities that are characteristic of interferon alfa-2a.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/pegasys-epar-product-information_en.pdf"},"copies":[]},{"key":"blinatumomab__blincyto","inn":"blinatumomab","brand":"Blincyto","company":"Amgen Europe B.V.","ema_product_number":"EMEA/H/C/003731","atc_code":"L01FX07","authorised":"2015-11-23","pi_updated":"2026-09-22","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/blincyto","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/blincyto-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/blincyto-epar-product-information_de.pdf","indication_text":"BLINCYTO is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome-positive B-cell precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options.\nBLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome-negative CD19 positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.\nBLINCYTO is indicated as monotherapy for the treatment of paediatric patients aged 1 month or older with Philadelphia chromosome-negative CD19 positive B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation.\nBLINCYTO is indicated as monotherapy for the treatment of paediatric patients aged 1 month or older with high-risk first relapsed Philadelphia chromosome-negative CD19 positive B-cell precursor ALL as part of the consolidation therapy (see section 4.2).\nBLINCYTO is indicated as monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome negative CD19 positive B-cell precursor ALL.","extracted":true,"target":{"targets":["CD19","CD3"],"modality":"bispecific antibody","label":"CD19 × CD3 bispecific antibody","mechanism":"Binds CD19 on B cells and CD3 on T cells to form a cytolytic synapse, activating endogenous T cells to induce targeted lysis of CD19-positive cells.","quote":"Blinatumomab is a bispecific T-cell engager molecule that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T-cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/blincyto-epar-product-information_en.pdf"},"copies":[]},{"key":"fruquintinib__fruzaqla","inn":"fruquintinib","brand":"Fruzaqla","company":"Takeda Pharmaceuticals International AG Ireland","ema_product_number":"EMEA/H/C/005979","atc_code":"L01EK","authorised":"2024-06-20","pi_updated":"2026-09-21","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/fruzaqla","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/fruzaqla-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/fruzaqla-epar-product-information_de.pdf","indication_text":"FRUZAQLA as monotherapy is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine-tipiracil or regorafenib.","extracted":true,"target":{"targets":["VEGFR1","VEGFR2","VEGFR3"],"modality":"small molecule","label":"VEGFR tyrosine kinase inhibitor","mechanism":"Fruquintinib selectively inhibits VEGFR-1, -2, and -3 tyrosine kinases, producing antitumor effects by suppressing tumour angiogenesis.","quote":"Fruquintinib is a selective tyrosine kinase inhibitor of VEGFR-1, -2, and -3 with antitumor effects resulting from suppression of tumour angiogenesis.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/fruzaqla-epar-product-information_en.pdf"},"copies":[]},{"key":"mirvetuximab-soravtansine__elahere","inn":"mirvetuximab soravtansine","brand":"Elahere","company":"AbbVie Deutschland GmbH & Co. KG","ema_product_number":"EMEA/H/C/005036","atc_code":"L01FX26","authorised":"2024-11-14","pi_updated":"2026-01-23","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/elahere","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/elahere-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/elahere-epar-product-information_de.pdf","indication_text":"ELAHERE as monotherapy is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens (see section 4.2).","extracted":true,"target":{"targets":["FRα"],"modality":"antibody-drug conjugate","label":"FRα-directed antibody-drug conjugate","mechanism":"Binds FRα on ovarian cancer cells and is internalised, releasing the microtubule inhibitor DM4, which disrupts microtubules and causes cell cycle arrest and apoptosis.","quote":"The antibody is an engineered IgG1 directed against folate receptor alpha (FRα).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/elahere-epar-product-information_en.pdf"},"copies":[]},{"key":"ripretinib__qinlock","inn":"ripretinib","brand":"Qinlock","company":"Deciphera Pharmaceuticals (Netherlands) B.V.","ema_product_number":"EMEA/H/C/005614","atc_code":"L01","authorised":"2021-11-18","pi_updated":"2026-09-17","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/qinlock","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/qinlock-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/qinlock-epar-product-information_de.pdf","indication_text":"QINLOCK is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.","extracted":true,"target":{"targets":["KIT","PDGFRA","PDGFRB","TIE2","VEGFR2","BRAF"],"modality":"small molecule","label":"KIT and PDGFRA kinase inhibitor","mechanism":"Tyrosine kinase inhibitor of KIT and PDGFRA, including wild-type, primary and secondary mutant forms; also inhibits PDGFRB, TIE2, VEGFR2 and BRAF in vitro.","quote":"Ripretinib is a novel tyrosine kinase inhibitor that inhibits KIT proto-oncogene receptor tyrosine kinase and PDGFRA kinase, including wild type, primary, and secondary mutations.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/qinlock-epar-product-information_en.pdf"},"copies":[]},{"key":"mirdametinib__ezmekly","inn":"mirdametinib","brand":"Ezmekly","company":"Merck Europe B.V. ","ema_product_number":"EMEA/H/C/006460","atc_code":"L01EE","authorised":"2025-07-17","pi_updated":"2026-09-16","conditional":true,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ezmekly","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/ezmekly-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/ezmekly-epar-product-information_de.pdf","indication_text":"Ezmekly as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric and adult patients with neurofibromatosis type 1 (NF1) aged 2 years and above.","extracted":true,"target":{"targets":["MEK1/2"],"modality":"small molecule","label":"MEK1/2 inhibitor","mechanism":"Mirdametinib selectively and non-competitively inhibits MEK1/2, blocking downstream signaling to inhibit tumour cell proliferation and survival.","quote":"Mirdametinib is a selective, non‑competitive inhibitor of mitogen‑activated protein kinase kinases 1 and 2 (MEK1/2).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/ezmekly-epar-product-information_en.pdf"},"copies":[]},{"key":"alpelisib__piqray","inn":"alpelisib","brand":"Piqray","company":"Novartis Europharm Limited","ema_product_number":"EMEA/H/C/004804","atc_code":"L01XE","authorised":"2020-07-27","pi_updated":"2026-09-16","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/piqray","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/piqray-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/piqray-epar-product-information_de.pdf","indication_text":"Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following an endocrine-based regimen (see section 5.1 and for biomarker-based patient selection see section 4.2).","extracted":true,"target":{"targets":["PI3Kα"],"modality":"small molecule","label":"PI3Kα inhibitor","mechanism":"Alpelisib selectively inhibits PI3Kα, blocking downstream PI3K/AKT signalling and reducing tumour growth in cancers harbouring PIK3CA mutations.","quote":"Alpelisib is an α-specific class I phosphatidylinositol3kinase (PI3Kα) inhibitor.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/piqray-epar-product-information_en.pdf"},"copies":[]},{"key":"alpelisib__vijoice","inn":"alpelisib","brand":"Vijoice","company":"Novartis Europharm Limited","ema_product_number":"EMEA/H/C/006539","atc_code":"L01EM03","authorised":"2026-07-15","pi_updated":"2026-08-26","conditional":true,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/vijoice","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/vijoice-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/vijoice-epar-product-information_de.pdf","indication_text":"Treatment of adult and paediatric patients aged 2 years and older with severe or life-threatening manifestations of PIK3CA-related overgrowth spectrum (PROS)","extracted":false,"target":null,"copies":[]},{"key":"pirtobrutinib__jaypirca","inn":"pirtobrutinib","brand":"Jaypirca","company":"Eli Lilly Nederland B.V.","ema_product_number":"EMEA/H/C/005863","atc_code":"L01","authorised":"2023-10-30","pi_updated":"2026-09-15","conditional":true,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/jaypirca","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/jaypirca-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/jaypirca-epar-product-information_de.pdf","indication_text":"Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor.\nJaypirca as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL).","extracted":true,"target":{"targets":["BTK"],"modality":"small molecule","label":"Noncovalent BTK inhibitor","mechanism":"Pirtobrutinib reversibly binds wild-type and C481-mutant BTK, inhibiting its kinase activity to block BCR-mediated B-cell proliferation, trafficking, and survival pathways.","quote":"Pirtobrutinib is a reversible, noncovalent inhibitor of BTK.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/jaypirca-epar-product-information_en.pdf"},"copies":[]},{"key":"sacituzumab-govitecan__trodelvy","inn":"sacituzumab govitecan","brand":"Trodelvy","company":"Gilead Sciences Ireland UC","ema_product_number":"EMEA/H/C/005182","atc_code":"L01FX06","authorised":"2021-11-22","pi_updated":"2026-09-15","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/trodelvy","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/trodelvy-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/trodelvy-epar-product-information_de.pdf","indication_text":"Triple-Negative Breast Cancer\nTrodelvy is indicated:\n• in combination with pembrolizumab, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10 (see sections 4.2 and 5.1).\n• as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy (see section 5.1).\n• as monotherapy for the treatment of adult patients with unresectable or metastatic TNBC who have received two or more prior systemic therapies, including at least one of them for advanced disease (see section 5.1) HR-Positive, HER2-Negative Breast Cancer Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting (see section 5.1).","extracted":true,"target":{"targets":["TROP2"],"modality":"antibody-drug conjugate","label":"TROP2-directed antibody-drug conjugate","mechanism":"Binds Trop-2-expressing tumour cells and internalises to release SN-38, which inhibits topoisomerase I, causing DNA damage and cell death.","quote":"Sacituzumab govitecan binds to Trop-2-expressing tumour cells and is internalised with the subsequent release of SN-38 from a hydrolysable linker.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/trodelvy-epar-product-information_en.pdf"},"copies":[]},{"key":"leuprorelin__camcevi","inn":"leuprorelin","brand":"Camcevi","company":"Accord Healthcare S.L.U.","ema_product_number":"EMEA/H/C/005034","atc_code":"","authorised":"2022-05-24","pi_updated":"2026-09-15","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/camcevi","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/camcevi-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/camcevi-epar-product-information_de.pdf","indication_text":"CAMCEVI is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.","extracted":true,"target":{"targets":["GnRH receptor"],"modality":"protein or peptide","label":"GnRH receptor agonist","mechanism":"Synthetic nonapeptide GnRH agonist that, given continuously, inhibits pituitary gonadotropin secretion and suppresses testicular steroidogenesis (testosterone production), reversibly.","quote":"Leuprorelin mesilate is a synthetic nonapeptide agonist of naturally occurring GnRH that, when given continuously, inhibits pituitary gonadotropin secretion and suppresses testicular steroidogenesis in males.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/camcevi-epar-product-information_en.pdf"},"copies":[]},{"key":"loncastuximab-tesirine__zynlonta","inn":"loncastuximab tesirine","brand":"Zynlonta","company":"Swedish Orphan Biovitrum AB","ema_product_number":"EMEA/H/C/005685","atc_code":"L01FX22","authorised":"2022-12-20","pi_updated":"2026-09-14","conditional":true,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zynlonta","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/zynlonta-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/zynlonta-epar-product-information_de.pdf","indication_text":"Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.","extracted":true,"target":{"targets":["CD19"],"modality":"antibody-drug conjugate","label":"CD19-directed antibody-drug conjugate","mechanism":"Binds to CD19 on B-lineage cells, is internalised, and releases SG3199 which forms cytotoxic DNA interstrand crosslinks to induce cell death.","quote":"Loncastuximab tesirine is an antibody-drug conjugate (ADC) targeting CD19.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/zynlonta-epar-product-information_en.pdf"},"copies":[]},{"key":"zolbetuximab__vyloy","inn":"zolbetuximab","brand":"Vyloy","company":"Astellas Pharma Europe B.V.","ema_product_number":"EMEA/H/C/005868","atc_code":"L01FX31","authorised":"2024-09-19","pi_updated":"2026-09-11","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/vyloy","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/vyloy-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/vyloy-epar-product-information_de.pdf","indication_text":"Vyloy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive (see section 4.2).","extracted":true,"target":{"targets":["CLDN18.2"],"modality":"monoclonal antibody","label":"CLDN18.2-directed monoclonal antibody","mechanism":"Zolbetuximab binds CLDN18.2 and depletes CLDN18.2-positive cells via antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity.","quote":"Zolbetuximab is a chimeric (mouse/human IgG1) monoclonal antibody directed against the tight junction molecule CLDN18.2.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/vyloy-epar-product-information_en.pdf"},"copies":[]},{"key":"osimertinib__tagrisso","inn":"osimertinib","brand":"Tagrisso","company":"AstraZeneca AB","ema_product_number":"EMEA/H/C/004124","atc_code":"L01XE","authorised":"2016-02-01","pi_updated":"2026-08-18","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tagrisso","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/tagrisso-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/tagrisso-epar-product-information_de.pdf","indication_text":"TAGRISSO as monotherapy is indicated for:\n• the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (see section 5.1).\n• the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy.\n• the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations.\n• the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.\nTAGRISSO is indicated in combination with:\n• pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.","extracted":true,"target":{"targets":["EGFR"],"modality":"small molecule","label":"EGFR tyrosine kinase inhibitor","mechanism":"Osimertinib is an irreversible inhibitor of epidermal growth factor receptors (EGFR) harboring sensitising mutations and the T790M resistance mutation.","quote":"It is an irreversible inhibitor of EGFRs harboring sensitising-mutations (EGFRm) and TKI-resistance mutation T790M.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/tagrisso-epar-product-information_en.pdf"},"copies":[]},{"key":"nirogacestat__ogsiveo","inn":"nirogacestat","brand":"Ogsiveo","company":"Merck Europe B.V.","ema_product_number":"EMEA/H/C/006071","atc_code":"L01XX81","authorised":"2025-08-14","pi_updated":"2026-09-02","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ogsiveo","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/ogsiveo-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/ogsiveo-epar-product-information_de.pdf","indication_text":"Ogsiveo as monotherapy is indicated for the treatment of adult patients with progressing desmoid tumours who require systemic treatment.","extracted":true,"target":{"targets":["gamma secretase"],"modality":"small molecule","label":"Gamma secretase inhibitor","mechanism":"Reversibly and non-competitively inhibits gamma secretase, blocking the proteolytic activation of Notch receptors.","quote":"Nirogacestat is a reversible and non‑competitive inhibitor of gamma secretase that blocks proteolytic activation of the Notch receptor.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/ogsiveo-epar-product-information_en.pdf"},"copies":[]},{"key":"tisagenlecleucel__kymriah","inn":"tisagenlecleucel","brand":"Kymriah","company":"Novartis Europharm Limited","ema_product_number":"EMEA/H/C/004090","atc_code":"L01XL04","authorised":"2018-08-23","pi_updated":"2026-09-01","conditional":false,"exceptional":false,"orphan":true,"prime":true,"advanced_therapy":true,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/kymriah","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/kymriah-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/kymriah-epar-product-information_de.pdf","indication_text":"Kymriah is indicated for the treatment of:\n• Paediatric and young adult patients up to and including 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse.\n• Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.\n• Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.","extracted":true,"target":{"targets":["CD19"],"modality":"cell therapy","label":"CD19-directed CAR T-cell therapy","mechanism":"Autologous CAR T cells recognise CD19 on target cells, activating T-cell signalling to expand, persist, and eliminate CD19-expressing cells.","quote":"The CAR is comprised of a murine single chain antibody fragment which recognises CD19 and is fused to intracellular signalling domains from 4-1BB (CD137) and CD3 zeta.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/kymriah-epar-product-information_en.pdf"},"copies":[]},{"key":"vorasidenib__voranigo","inn":"vorasidenib","brand":"Voranigo","company":"Les Laboratoires Servier","ema_product_number":"EMEA/H/C/006284","atc_code":"L01XM04","authorised":"2025-09-17","pi_updated":"2026-08-27","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/voranigo","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/voranigo-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/voranigo-epar-product-information_de.pdf","indication_text":"Voranigo as monotherapy is indicated for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy (see section 5.1).","extracted":true,"target":{"targets":["IDH1","IDH2"],"modality":"small molecule","label":"Dual mutant IDH1 and IDH2 inhibitor","mechanism":"Inhibits mutant IDH1 and IDH2 enzymes to suppress abnormal 2-HG production, promoting malignant cell differentiation and reducing proliferation.","quote":"Vorasidenib is an inhibitor that targets the mutant IDH1 and IDH2 enzymes.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/voranigo-epar-product-information_en.pdf"},"copies":[]},{"key":"teclistamab__tecvayli","inn":"teclistamab","brand":"Tecvayli","company":null,"ema_product_number":"EMEA/H/C/005865","atc_code":"L01FX24","authorised":"2022-08-23","pi_updated":"2026-08-27","conditional":false,"exceptional":false,"orphan":false,"prime":true,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tecvayli","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/tecvayli-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/tecvayli-epar-product-information_de.pdf","indication_text":"TECVAYLI is indicated  in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.\n as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.","extracted":true,"target":{"targets":["BCMA","CD3"],"modality":"bispecific antibody","label":"BCMA × CD3 bispecific antibody","mechanism":"Teclistamab binds CD3 on T cells and BCMA on myeloma cells, bringing them together to trigger T-cell activation and subsequent lysis of BCMA-positive cells.","quote":"Teclistamab is a full-size, IgG4-PAA bispecific antibody that targets the CD3 receptor expressed on the surface of T cells and B cell maturation antigen (BCMA), which is expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B cells and plasma cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/tecvayli-epar-product-information_en.pdf"},"copies":[]},{"key":"belantamab-mafodotin__blenrep","inn":"belantamab mafodotin","brand":"Blenrep","company":"GlaxoSmithKline Trading Services Limited","ema_product_number":"EMEA/H/C/006511","atc_code":"L01FX15","authorised":"2025-07-23","pi_updated":"2026-08-26","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/blenrep","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/blenrep-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/blenrep-epar-product-information_de.pdf","indication_text":"Blenrep is indicated in adults for the treatment of relapsed or refractory multiple myeloma:\n• in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and\n• in combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide.","extracted":true,"target":{"targets":["BCMA"],"modality":"antibody-drug conjugate","label":"BCMA-directed antibody-drug conjugate","mechanism":"Binds to cell surface BCMA and internalises to release mcMMAF, disrupting microtubules to cause apoptosis, while also recruiting immune effector cells to kill tumour cells.","quote":"Belantamab mafodotin binds to cell surface BCMA and is rapidly internalised.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/blenrep-epar-product-information_en.pdf"},"copies":[]},{"key":"daratumumab__darzalex","inn":"daratumumab","brand":"Darzalex","company":null,"ema_product_number":"EMEA/H/C/004077","atc_code":"L01FC01","authorised":"2016-05-20","pi_updated":"2026-07-21","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/darzalex-epar-product-information_de.pdf","indication_text":"DARZALEX is indicated:\n in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.\n in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.\n in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.\n as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.\nMultiple myeloma\n in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma.\n in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5.1).\nSmouldering multiple myeloma\nDARZALEX as monotherapy is indicated for the treatment of adult patients with smouldering multiple myeloma at high risk of developing multiple myeloma (see section 5.1).\nLight chain (AL) amyloidosis\nDARZALEX is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic AL amyloidosis.","extracted":true,"target":{"targets":["CD38"],"modality":"monoclonal antibody","label":"Anti-CD38 monoclonal antibody","mechanism":"Binds to CD38 on tumour cells, inducing cell lysis via complement-dependent cytotoxicity, ADCC, ADCP, and apoptosis, while depleting immunosuppressive cells.","quote":"Daratumumab is an IgG1κ human monoclonal antibody (mAb) that binds to the CD38 protein expressed at a high level on the surface of multiple myeloma tumour cells, as well as other cell types and tissues at various levels.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf"},"copies":[]},{"key":"abemaciclib__verzenios","inn":"abemaciclib","brand":"Verzenios","company":"Eli Lilly Nederland B.V.","ema_product_number":"EMEA/H/C/004302","atc_code":"L01EF03","authorised":"2018-09-26","pi_updated":"2026-08-25","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/verzenios","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/verzenios-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/verzenios-epar-product-information_de.pdf","indication_text":"Early breast cancer\nVerzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence (see section 5.1).\nIn pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.\nAdvanced or metastatic breast cancer\nVerzenios is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.\nIn pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.","extracted":true,"target":{"targets":["CDK4","CDK6"],"modality":"small molecule","label":"CDK4/6 inhibitor","mechanism":"Inhibits CDK4 and CDK6, blocking retinoblastoma protein phosphorylation and arresting cell cycle progression from the G1 to the S phase to suppress tumour growth.","quote":"Abemaciclib is a potent and selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), and most active against Cyclin D1/CDK4 in enzymatic assays.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/verzenios-epar-product-information_en.pdf"},"copies":[]},{"key":"adagrasib__krazati","inn":"adagrasib","brand":"Krazati","company":"Bristol-Myers Squibb Pharma EEIG","ema_product_number":"EMEA/H/C/006013","atc_code":"L01XX77","authorised":"2024-01-05","pi_updated":"2026-08-21","conditional":true,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/krazati","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/krazati-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/krazati-epar-product-information_de.pdf","indication_text":"KRAZATI as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and disease progression after at least one prior systemic therapy.","extracted":true,"target":{"targets":["KRAS G12C"],"modality":"small molecule","label":"KRAS G12C inhibitor","mechanism":"Covalently binds mutant cysteine in KRAS G12C, locking it in an inactive GDP-bound conformation to inhibit downstream signalling and tumour growth.","quote":"Adagrasib is a selective, irreversible inhibitor of KRAS (Kirsten rat sarcoma viral oncogene homolog) G12C that covalently binds to the mutant cysteine in KRAS G12C and locks the mutant KRAS protein in its inactive, GDP-bound conformation, which prevents KRAS-dependent downstream signalling.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/krazati-epar-product-information_en.pdf"},"copies":[]},{"key":"rucaparib__rubraca","inn":"rucaparib","brand":"Rubraca","company":"pharmaand GmbH","ema_product_number":"EMEA/H/C/004272","atc_code":"L01XX","authorised":"2018-05-23","pi_updated":"2025-11-27","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/rubraca","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/rubraca-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/rubraca-epar-product-information_de.pdf","indication_text":"Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.\nRubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.","extracted":true,"target":{"targets":["PARP1","PARP2","PARP3"],"modality":"small molecule","label":"PARP inhibitor","mechanism":"Inhibits PARP enzymatic activity and traps PARP-DNA complexes, resulting in increased DNA damage, apoptosis, and cell death.","quote":"Rucaparib is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, including PARP-1, PARP-2, and PARP-3, which play a role in DNA repair.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/rubraca-epar-product-information_en.pdf"},"copies":[]},{"key":"ribociclib__kisqali","inn":"ribociclib","brand":"Kisqali","company":"Novartis Europharm Limited","ema_product_number":"EMEA/H/C/004213","atc_code":"L01EF02","authorised":"2017-08-22","pi_updated":"2026-08-19","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/kisqali","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/kisqali-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/kisqali-epar-product-information_de.pdf","indication_text":"Early breast cancer\nKisqali in combination with an aromatase inhibitor is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence (see section 5.1 for selection criteria).\nIn pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.\nAdvanced or metastatic breast cancer\nKisqali is indicated for the treatment of women with HR-positive, HER2-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.\nIn pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.","extracted":true,"target":{"targets":["CDK4/6"],"modality":"small molecule","label":"CDK4/6 inhibitor","mechanism":"Ribociclib selectively inhibits CDK4 and CDK6, decreasing retinoblastoma protein phosphorylation and causing G1 cell cycle arrest and reduced proliferation.","quote":"Ribociclib is a selective inhibitor of cyclin-dependent kinase (CDK) 4 and 6, resulting in 50% inhibition (IC50) values of 0.01 (4.3 ng/ml) and 0.039 μM (16.9 ng/ml) in biochemical assays, respectively.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/kisqali-epar-product-information_en.pdf"},"copies":[]},{"key":"quizartinib__vanflyta","inn":"quizartinib","brand":"Vanflyta","company":"Daiichi Sankyo Europe GmbH","ema_product_number":"EMEA/H/C/005910","atc_code":"L01EX11","authorised":"2023-11-06","pi_updated":"2026-08-19","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/vanflyta","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/vanflyta-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/vanflyta-epar-product-information_de.pdf","indication_text":"VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive.","extracted":true,"target":{"targets":["FLT3"],"modality":"small molecule","label":"FLT3 inhibitor","mechanism":"Quizartinib competitively binds the ATP-binding pocket of FLT3 to inhibit kinase activity, preventing autophosphorylation, downstream receptor signalling, and FLT3-ITD-dependent proliferation.","quote":"Quizartinib is an inhibitor of the receptor tyrosine kinase FLT3.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/vanflyta-epar-product-information_en.pdf"},"copies":[]},{"key":"fedratinib__inrebic","inn":"fedratinib","brand":"Inrebic","company":"Bristol Myers Squibb Pharma EEIG","ema_product_number":"EMEA/H/C/005026","atc_code":"L01EJ02","authorised":"2021-02-08","pi_updated":"2026-08-19","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/inrebic","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/inrebic-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/inrebic-epar-product-information_de.pdf","indication_text":"Inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.","extracted":true,"target":{"targets":["JAK2","FLT3"],"modality":"small molecule","label":"JAK2 inhibitor","mechanism":"Fedratinib selectively inhibits JAK2 and FLT3, reducing JAK2-mediated phosphorylation of STAT3 and STAT5 proteins and inhibiting malignant cell proliferation.","quote":"Fedratinib is a kinase inhibitor with activity against wild type and mutationally activated Janus Associated Kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/inrebic-epar-product-information_en.pdf"},"copies":[]},{"key":"niraparib-abiraterone-acetate__akeega","inn":"niraparib;abiraterone acetate","brand":"Akeega","company":null,"ema_product_number":"EMEA/H/C/005932","atc_code":"L01","authorised":"2023-04-19","pi_updated":"2026-03-17","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/akeega","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/akeega-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/akeega-epar-product-information_de.pdf","indication_text":"Akeega is indicated with prednisone or prednisolone:\n in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA 1/2 mutations (germline and/or somatic).\n for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA 1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.","extracted":true,"target":{"targets":["PARP1","PARP2","CYP17A1"],"modality":"small molecule","label":"PARP and CYP17 inhibitor combination","mechanism":"Niraparib inhibits PARP-1 and PARP-2 to impair DNA repair and trigger cell death, while abiraterone inhibits CYP17 to block androgen biosynthesis in testicular, adrenal, and prostatic tissues.","quote":"Akeega is a combination of niraparib, an inhibitor of poly(ADP-ribose) polymerase (PARP), and abiraterone acetate (a prodrug of abiraterone), a CYP17 inhibitor targeting two oncogenic dependencies in patients with metastatic prostate cancer and HRR gene mutations.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/akeega-epar-product-information_en.pdf"},"copies":[]},{"key":"lutetium-177lu-oxodotreotide__lutathera","inn":"lutetium (177Lu) oxodotreotide","brand":"Lutathera","company":"Novartis Europharm Limited","ema_product_number":"EMEA/H/C/004123","atc_code":"V10XX04","authorised":"2017-09-26","pi_updated":"2026-08-14","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lutathera","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/lutathera-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/lutathera-epar-product-information_de.pdf","indication_text":"Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well-differentiated (G1 and G2), somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.","extracted":true,"target":{"targets":["SSTR2"],"modality":"radioligand","label":"SSTR2-targeted radioligand","mechanism":"Binds to subtype 2 somatostatin receptors on tumour cells and delivers beta-minus radiation to cause targeted cell death.","quote":"Lutetium (177Lu) oxodotreotide has a high affinity for subtype 2 somatostatin receptors (SSTR2).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/lutathera-epar-product-information_en.pdf"},"copies":[]},{"key":"olaparib__lynparza","inn":"olaparib","brand":"Lynparza","company":"AstraZeneca AB","ema_product_number":"EMEA/H/C/003726","atc_code":"L01XK01","authorised":"2014-12-16","pi_updated":"2026-02-19","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lynparza","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/lynparza-epar-product-information_de.pdf","indication_text":"Ovarian cancer\nLynparza is indicated as monotherapy for the:\n• maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.\n• maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.\nLynparza in combination with bevacizumab is indicated for the:\n• maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability (see section 5.1).\nBreast cancer\nLynparza is indicated as:\n• monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 and 5.1).\n• monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments (see section 5.1). Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.\nAdenocarcinoma of the pancreas\nLynparza is indicated as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.\nProstate cancer\nLynparza is indicated:\n• as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.\n• in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated (see section 5.1).\nEndometrial cancer\nLynparza in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel.","extracted":true,"target":{"targets":["PARP-1","PARP-2","PARP-3"],"modality":"small molecule","label":"PARP inhibitor","mechanism":"Olaparib inhibits PARP-1, PARP-2, and PARP-3 and traps PARP on DNA, blocking single-strand break repair and inducing double-strand breaks that lead to cell death in homologous recombination-deficient tumour cells.","quote":"Olaparib is a potent inhibitor of human poly (ADP-ribose) polymerase enzymes (PARP-1, PARP-2, and PARP-3), and has been shown to inhibit the growth of selected tumour cell lines in vitro and tumour growth in vivo either as a standalone treatment or in combination with established chemotherapies or new hormonal agents (NHA).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf"},"copies":[]},{"key":"asciminib__scemblix","inn":"asciminib","brand":"Scemblix","company":"Novartis Europharm Limited","ema_product_number":"EMEA/H/C/005605","atc_code":"L01EA06","authorised":"2022-08-25","pi_updated":"2026-08-07","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/scemblix","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/scemblix-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/scemblix-epar-product-information_de.pdf","indication_text":"Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) (see section 5.1).\nScemblix is indicated for the treatment of adult patients with Ph+ CML-CP with the T315I mutation who are resistant to, intolerant to or ineligible for ponatinib (see section 5.1).","extracted":true,"target":{"targets":["BCR::ABL1","ABL1"],"modality":"small molecule","label":"Allosteric BCR::ABL1 inhibitor (myristoyl pocket)","mechanism":"Binds the ABL myristoyl pocket of the BCR::ABL1 fusion protein, inhibiting its ABL1 tyrosine kinase activity.","quote":"Asciminib inhibits the ABL1 kinase activity of the BCR::ABL1 fusion protein by specifically targeting the ABL myristoyl pocket.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/scemblix-epar-product-information_en.pdf"},"copies":[]},{"key":"lisocabtagene-maraleucel__breyanzi","inn":"lisocabtagene maraleucel","brand":"Breyanzi","company":"Bristol-Myers Squibb Pharma EEIG","ema_product_number":"EMEA/H/C/004731","atc_code":"L01XL08","authorised":"2022-04-04","pi_updated":"2026-08-06","conditional":false,"exceptional":false,"orphan":false,"prime":true,"advanced_therapy":true,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/breyanzi","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/breyanzi-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/breyanzi-epar-product-information_de.pdf","indication_text":"Breyanzi is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.\nBreyanzi is indicated for the treatment of adult patients with relapsed or refractory DLBCL, PMBCL and FL3B, after two or more lines of systemic therapy.\nBreyanzi is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.\nBreyanzi is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.","extracted":true,"target":{"targets":["CD19"],"modality":"cell therapy","label":"CD19-directed CAR T-cell therapy","mechanism":"CAR binding to CD19 on tumour and normal B cells activates CAR T cells, inducing proliferation, cytokine release, and cytotoxic killing of target cells.","quote":"CAR binding to CD19 expressed on the cell surface of tumour and normal B-cells induces activation and proliferation of CAR T-cells, release of pro-inflammatory cytokines, and cytotoxic killing of target cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/breyanzi-epar-product-information_en.pdf"},"copies":[]},{"key":"epcoritamab__tepkinly","inn":"epcoritamab","brand":"Tepkinly","company":"AbbVie Deutschland GmbH & Co. KG","ema_product_number":"EMEA/H/C/005985","atc_code":"L01FX27","authorised":"2023-09-22","pi_updated":"2026-08-06","conditional":true,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tepkinly","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/tepkinly-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/tepkinly-epar-product-information_de.pdf","indication_text":"Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.\nTepkinly in combination with lenalidomide and rituximab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).\nTepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.","extracted":true,"target":{"targets":["CD20","CD3"],"modality":"bispecific antibody","label":"CD20 × CD3 bispecific antibody","mechanism":"Epcoritamab simultaneously binds CD20 on B cells and CD3 on T cells, inducing T-cell activation and T-cell-mediated killing of CD20-expressing cancer cells.","quote":"Epcoritamab is a humanised IgG1-bispecific antibody that binds to a specific extracellular epitope of CD20 on B cells and to CD3 on T cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/tepkinly-epar-product-information_en.pdf"},"copies":[]},{"key":"ixazomib__ninlaro","inn":"ixazomib","brand":"Ninlaro","company":"Takeda Pharma A/S","ema_product_number":"EMEA/H/C/003844","atc_code":"L01XG03","authorised":"2016-11-21","pi_updated":"2026-08-05","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ninlaro","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/ninlaro-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/ninlaro-epar-product-information_de.pdf","indication_text":"NINLARO in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.","extracted":true,"target":{"targets":["PSMB5"],"modality":"small molecule","label":"Proteasome inhibitor","mechanism":"Oral prodrug whose active form reversibly binds and inhibits the chymotrypsin-like activity of the 20S proteasome beta 5 subunit, inducing tumour cell apoptosis.","quote":"Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/ninlaro-epar-product-information_en.pdf"},"copies":[]},{"key":"selinexor__nexpovio","inn":"selinexor","brand":"Nexpovio","company":"Stemline Therapeutics B.V.","ema_product_number":"EMEA/H/C/005127","atc_code":"L01XX66","authorised":"2021-03-26","pi_updated":"2026-08-05","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/nexpovio","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/nexpovio-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/nexpovio-epar-product-information_de.pdf","indication_text":"NEXPOVIO is indicated:\n• in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.\n• in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.","extracted":true,"target":{"targets":["XPO1"],"modality":"small molecule","label":"Exportin 1 (XPO1) inhibitor","mechanism":"Selinexor selectively blocks exportin 1 (XPO1), leading to nuclear accumulation of tumour suppressor proteins, cell cycle arrest, down-regulation of oncoproteins, and cancer cell apoptosis.","quote":"Selinexor is a reversible covalent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/nexpovio-epar-product-information_en.pdf"},"copies":[]},{"key":"carfilzomib__kyprolis","inn":"carfilzomib","brand":"Kyprolis","company":"Amgen Europe B.V.","ema_product_number":"EMEA/H/C/003790","atc_code":"L01XX45","authorised":"2015-11-19","pi_updated":"2026-08-05","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/kyprolis","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/kyprolis-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/kyprolis-epar-product-information_de.pdf","indication_text":"Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.1).","extracted":true,"target":{"targets":["20S proteasome"],"modality":"small molecule","label":"Proteasome inhibitor","mechanism":"Selectively and irreversibly binds the active sites of the 20S proteasome, inhibiting proteasome activity and inducing proapoptotic and antiproliferative effects.","quote":"Carfilzomib is a tetrapeptide epoxyketone proteasome inhibitor that selectively and irreversibly binds to the N terminal threonine containing active sites of the 20S proteasome, the proteolytic core particle within the 26S proteasome, and displays little to no activity against other protease classes.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/kyprolis-epar-product-information_en.pdf"},"copies":[]},{"key":"vandetanib__caprelsa","inn":"vandetanib","brand":"Caprelsa","company":"Esteve Pharmaceuticals, S.A.","ema_product_number":"EMEA/H/C/002315","atc_code":"L01XE","authorised":"2012-02-16","pi_updated":"2026-08-05","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/caprelsa","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/caprelsa-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/caprelsa-epar-product-information_de.pdf","indication_text":"Caprelsa is indicated for the treatment of aggressive and symptomatic Rearranged during Transfection (RET) mutant medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.\nCaprelsa is indicated in adults, children and adolescents aged 5 years and older.","extracted":true,"target":{"targets":["VEGFR2","EGFR","RET","VEGFR3"],"modality":"small molecule","label":"Multikinase inhibitor (VEGFR, EGFR, RET)","mechanism":"Inhibits VEGFR-2, EGFR, and RET tyrosine kinases, thereby reducing angiogenesis, vascular permeability, and tumor cell proliferation and survival.","quote":"Vandetanib is a potent inhibitor of vascular endothelial growth factor receptor-2 (VEGFR-2 also known as kinase insert domain containing receptor [KDR]), epidermal growth factor receptor (EGFR) and RET tyrosine kinases.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/caprelsa-epar-product-information_en.pdf"},"copies":[]},{"key":"toripalimab__loqtorzi","inn":"toripalimab","brand":"Loqtorzi","company":"Topalliance Biosciences Europe Limited","ema_product_number":"EMEA/H/C/006120","atc_code":"L01FF13","authorised":"2024-09-19","pi_updated":"2026-08-04","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/loqtorzi","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/loqtorzi-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/loqtorzi-epar-product-information_de.pdf","indication_text":"LOQTORZI, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma.\nLOQTORZI, in combination with cisplatin and paclitaxel, is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma.","extracted":true,"target":{"targets":["PD-1"],"modality":"monoclonal antibody","label":"PD-1 inhibitor (antibody)","mechanism":"Toripalimab binds to the PD-1 receptor, blocking interaction with PD-L1 and PD-L2 to release PD-1 pathway-mediated inhibition of the anti-tumour immune response.","quote":"Toripalimab is a humanised IgG4 monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumour immune response.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/loqtorzi-epar-product-information_en.pdf"},"copies":[]},{"key":"elacestrant__orserdu","inn":"elacestrant","brand":"Orserdu","company":"Stemline Therapeutics B.V.","ema_product_number":"EMEA/H/C/005898","atc_code":"L02BA","authorised":"2023-09-15","pi_updated":"2026-08-04","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/orserdu","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/orserdu-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/orserdu-epar-product-information_de.pdf","indication_text":"ORSERDU monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.","extracted":true,"target":{"targets":["ERα"],"modality":"small molecule","label":"Selective estrogen receptor degrader","mechanism":"Elacestrant is an oral, selective antagonist and degrader of estrogen receptor-α (ERα).","quote":"Elacestrant, a tetrahydronaphthalene compound, is a potent, selective and orally active estrogen receptor-α (ERα) antagonist and degrader.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/orserdu-epar-product-information_en.pdf"},"copies":[]},{"key":"larotrectinib__vitrakvi","inn":"larotrectinib","brand":"Vitrakvi","company":"Bayer AG","ema_product_number":"EMEA/H/C/004919","atc_code":"L01XE53","authorised":"2019-09-19","pi_updated":"2026-08-04","conditional":true,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/vitrakvi","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/vitrakvi-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/vitrakvi-epar-product-information_de.pdf","indication_text":"VITRAKVI as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion,\n- who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and\n- who have no satisfactory treatment options (see sections 4.4 and 5.1).","extracted":true,"target":{"targets":["TRKA","TRKB","TRKC"],"modality":"small molecule","label":"Selective TRK inhibitor","mechanism":"Larotrectinib is a selective ATP-competitive inhibitor of TRKA, TRKB and TRKC that blocks constitutive kinase activity of oncogenic TRK fusion proteins driving proliferation and survival.","quote":"The target for larotrectinib is the TRK family of proteins inclusive of TRKA, TRKB, and TRKC that are encoded by NTRK1, NTRK2 and NTRK3 genes, respectively.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/vitrakvi-epar-product-information_en.pdf"},"copies":[]},{"key":"ponatinib__iclusig","inn":"ponatinib","brand":"Iclusig","company":"Incyte Biosciences Distribution B.V.","ema_product_number":"EMEA/H/C/002695","atc_code":"L01EA05","authorised":"2013-07-01","pi_updated":"2026-07-31","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/iclusig","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/iclusig-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/iclusig-epar-product-information_de.pdf","indication_text":"Iclusig is indicated as monotherapy in adult patients with\n• chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation\n• Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.\nIclusig is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Ph+ ALL (see section 5.1).\nIclusig is indicated as monotherapy in paediatric patients 6 years of age or older with\n• chronic phase chronic myeloid leukaemia (CP-CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.\nSee sections 4.2 for the assessment of cardiovascular status prior to start of therapy and 4.4 for situations where an alternative treatment may be considered.","extracted":true,"target":{"targets":["BCR-ABL"],"modality":"small molecule","label":"Pan BCR-ABL tyrosine kinase inhibitor","mechanism":"Binds with high affinity to native BCR-ABL and mutant forms of the ABL kinase, inhibiting their kinase activity.","quote":"Ponatinib is a potent pan BCR-ABL inhibitor with structural elements, including a carbon-carbon triple-bond, that enable high affinity binding to native BCR-ABL and mutant forms of the ABL kinase.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/iclusig-epar-product-information_en.pdf"},"copies":[]},{"key":"sotorasib__lumykras","inn":"sotorasib","brand":"Lumykras","company":"Amgen Europe B.V.","ema_product_number":"EMEA/H/C/005522","atc_code":"L01XX73","authorised":"2022-01-06","pi_updated":"2026-10-08","conditional":true,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lumykras","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/lumykras-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/lumykras-epar-product-information_de.pdf","indication_text":"LUMYKRAS as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C-mutation and who have progressed after at least one prior line of systemic therapy.","extracted":true,"target":{"targets":["KRAS G12C"],"modality":"small molecule","label":"KRAS G12C inhibitor","mechanism":"Sotorasib covalently and irreversibly binds to KRAS G12C, blocking downstream tumour cell signalling and survival, inhibiting growth, and promoting apoptosis.","quote":"Sotorasib is a selective KRAS G12C (Kirsten rat sarcoma viral oncogene homologue) inhibitor, which covalently and irreversibly binds to the unique cysteine of KRAS G12C.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/lumykras-epar-product-information_en.pdf"},"copies":[]},{"key":"encorafenib__braftovi","inn":"encorafenib","brand":"Braftovi","company":"Pierre Fabre Medicament","ema_product_number":"EMEA/H/C/004580","atc_code":"L01EC03","authorised":"2018-09-19","pi_updated":"2026-07-01","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/braftovi","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/braftovi-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/braftovi-epar-product-information_de.pdf","indication_text":"Melanoma\nEncorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.\nColorectal cancer (CRC)\n• Encorafenib in combination with cetuximab is indicated for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, who have received prior systemic therapy.\n• Encorafenib in combination with cetuximab and FOLFOX is indicated for the first line treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation.\nNon-small cell lung cancer (NSCLC)\nEncorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.\nFor biomarker-based patient selection, see section 4.2","extracted":true,"target":{"targets":["BRAF V600E","BRAF","CRAF"],"modality":"small molecule","label":"BRAF inhibitor","mechanism":"ATP-competitive RAF kinase inhibitor (BRAF V600E, BRAF, CRAF) that suppresses RAF/MEK/ERK signalling and growth of BRAF V600-mutant tumour cells; it does not inhibit signalling in wild-type BRAF cells.","quote":"The half maximal inhibitory concentration (IC50) of encorafenib against BRAF V600E, BRAF and CRAF enzymes was determined to be 0.35, 0.47 and 0.30 nM, respectively.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/braftovi-epar-product-information_en.pdf"},"copies":[]},{"key":"atezolizumab__tecentriq","inn":"atezolizumab","brand":"Tecentriq","company":"Roche Registration GmbH","ema_product_number":"EMEA/H/C/004143","atc_code":"L01XC32","authorised":"2017-09-20","pi_updated":"2026-07-21","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tecentriq","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/tecentriq-epar-product-information_de.pdf","indication_text":"Urothelial carcinoma (UC)\nTecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic UC:\n after prior platinum-containing chemotherapy, or  who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1).\nEarly-stage non-small cell lung cancer (NSCLC)\nTecentriq as monotherapy is indicated as adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TC) and who do not have EGFR-mutant or ALK-positive NSCLC (see section 5.1 for selection criteria).\nAdvanced NSCLC\nTecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC. In patients with EGFR-mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5.1).\nTecentriq, in combination with nab-paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR-mutant or ALK-positive NSCLC (see section 5.1).\nTecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumours have a PD-L1 expression ≥ 50% TC or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR-mutant or ALK-positive NSCLC (see section 5.1).\nTecentriq as monotherapy is indicated for the first-line treatment of adult patients with advanced NSCLC who are ineligible for platinum-based therapy (see section 5.1 for selection criteria).\nTecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR-mutant or ALK-positive NSCLC should also have received targeted therapies before receiving Tecentriq (see section 5.1).\nSmall cell lung cancer (SCLC)\nTecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (see section 5.1).\nTriple-negative breast cancer (TNBC)\nTecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.\nHepatocellular carcinoma (HCC)\nTecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable HCC who have not received prior systemic therapy (see section 5.1).","extracted":true,"target":{"targets":["PD-L1"],"modality":"monoclonal antibody","label":"PD-L1 inhibitor (antibody)","mechanism":"Atezolizumab binds directly to PD-L1, blocking its interaction with PD-1 and B7.1 receptors to relieve immune suppression and reactivate the antitumor immune response.","quote":"Atezolizumab is an Fc-engineered, humanised immunoglobulin G1 (IgG1) monoclonal antibody that directly binds to PD-L1 and provides a dual blockade of the PD-1 and B7.1 receptors, releasing PD-L1/PD-1 mediated inhibition of the immune response, including reactivating the antitumour immune response without inducing antibody-dependent cellular cytotoxicity.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf"},"copies":[]},{"key":"lutetium-177lu-vipivotide-tetraxetan__pluvicto","inn":"lutetium (177Lu) vipivotide tetraxetan","brand":"Pluvicto","company":"Novartis Europharm Limited","ema_product_number":"EMEA/H/C/005483","atc_code":"V10XX","authorised":"2022-12-09","pi_updated":"2026-07-20","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/pluvicto","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/pluvicto-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/pluvicto-epar-product-information_de.pdf","indication_text":"Pluvicto in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane-based chemotherapy (see section 5.1).","extracted":true,"target":{"targets":["PSMA"],"modality":"radioligand","label":"PSMA-directed radioligand therapy","mechanism":"Binds to PSMA on prostate cancer cells to deliver targeted beta-minus radiation from lutetium-177, causing DNA damage and cell death.","quote":"The active moiety of Pluvicto is the radionuclide lutetium-177 which is linked to a small-molecule ligand that targets and binds with high affinity to PSMA, a transmembrane protein that is highly expressed in prostate cancer, including mCRPC.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/pluvicto-epar-product-information_en.pdf"},"copies":[]},{"key":"amivantamab__rybrevant","inn":"amivantamab","brand":"Rybrevant","company":null,"ema_product_number":"EMEA/H/C/005454","atc_code":"L01FX18","authorised":"2021-12-09","pi_updated":"2026-07-16","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/rybrevant","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/rybrevant-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/rybrevant-epar-product-information_de.pdf","indication_text":"Rybrevant is indicated:\n in combination with lazertinib for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations.\n in combination with carboplatin and pemetrexed for the treatment of adult patients with advanced NSCLC with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI).\n in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations.\n as monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum-based therapy.\nRybrevant subcutaneous formulation is indicated:","extracted":true,"target":{"targets":["EGFR","MET"],"modality":"bispecific antibody","label":"EGFR × MET bispecific antibody","mechanism":"Binds extracellular domains of EGFR and MET, blocking ligand binding, promoting receptor degradation, and directing immune effector cell destruction via ADCC and trogocytosis.","quote":"Amivantamab binds to the extracellular domains of EGFR and MET.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/rybrevant-epar-product-information_en.pdf"},"copies":[]},{"key":"cetuximab__erbitux","inn":"cetuximab","brand":"Erbitux","company":"Merck Europe B.V. ","ema_product_number":"EMEA/H/C/000558","atc_code":"L01FE01","authorised":"2004-06-29","pi_updated":"2026-07-15","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/erbitux","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/erbitux-epar-product-information_de.pdf","indication_text":"Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer\n• in combination with irinotecan-based chemotherapy,\n• in first-line in combination with FOLFOX,\n• as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.\nFor details, see section 5.1.\nErbitux is indicated for the treatment of adult patients with BRAF V600E mutant metastatic colorectal cancer\n• in combination with encorafenib and FOLFOX for the first line treatment.\n• in combination with encorafenib in patients who have received prior systemic therapy.\nFor details, see section 5.1, for biomarker-based patient selection, see section 4.2.\nErbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck\n• in combination with radiation therapy for locally advanced disease,\n• in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.","extracted":true,"target":{"targets":["EGFR"],"modality":"monoclonal antibody","label":"EGFR-directed monoclonal antibody","mechanism":"Binds EGFR to block ligand binding, induce receptor internalisation and down-regulation, and trigger antibody-dependent cell-mediated cytotoxicity (ADCC).","quote":"Cetuximab is a chimeric monoclonal IgG1 antibody that is specifically directed against the epidermal growth factor receptor (EGFR).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/erbitux-epar-product-information_en.pdf"},"copies":[]},{"key":"venetoclax__venclyxto","inn":"venetoclax","brand":"Venclyxto","company":"AbbVie Deutschland GmbH & Co. KG","ema_product_number":"EMEA/H/C/004106","atc_code":"L01XX52","authorised":"2016-12-04","pi_updated":"2026-07-08","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/venclyxto","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/venclyxto-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/venclyxto-epar-product-information_de.pdf","indication_text":"Venclyxto is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL):\n• in combination with acalabrutinib with or without obinutuzumab\n• in combination with obinutuzumab (see section 5.1)\n• in combination with ibrutinib Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.\nVenclyxto monotherapy is indicated for the treatment of CLL:\n• in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or\n• in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.\nVenclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.","extracted":true,"target":{"targets":["BCL-2"],"modality":"small molecule","label":"BCL-2 inhibitor","mechanism":"Venetoclax selectively binds the BH3 groove of BCL-2, displacing pro-apoptotic proteins to induce mitochondrial outer membrane permeabilization, caspase activation, and programmed cell death.","quote":"Venetoclax is a potent, selective inhibitor of B-cell lymphoma (BCL)-2, an anti-apoptotic protein.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/venclyxto-epar-product-information_en.pdf"},"copies":[]},{"key":"isatuximab__sarclisa","inn":"isatuximab","brand":"Sarclisa","company":"Sanofi Winthrop Industrie","ema_product_number":"EMEA/H/C/004977","atc_code":"L01XC38","authorised":"2020-05-30","pi_updated":"2026-07-07","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/sarclisa","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/sarclisa-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/sarclisa-epar-product-information_de.pdf","indication_text":"Isatuximab is indicated:\n- in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.\n- in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.1).\n- in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.\n- in combination with bortezomib, lenalidomide, and dexamethasone, for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.","extracted":true,"target":{"targets":["CD38"],"modality":"monoclonal antibody","label":"CD38-directed monoclonal antibody","mechanism":"Binds CD38 on myeloma cells to trigger tumour cell death via ADCC, ADCP, CDC, and apoptosis, while inhibiting CD38 enzymatic activity.","quote":"Isatuximab is an IgG1-derived monoclonal antibody that binds to a specific extracellular epitope of CD38 receptor.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/sarclisa-epar-product-information_en.pdf"},"copies":[]},{"key":"selpercatinib__retsevmo","inn":"selpercatinib","brand":"Retsevmo","company":"Eli Lilly Nederland B.V.","ema_product_number":"EMEA/H/C/005375","atc_code":"L01EX22","authorised":"2021-02-11","pi_updated":"2026-07-03","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/retsevmo","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/retsevmo-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/retsevmo-epar-product-information_de.pdf","indication_text":"Retsevmo as monotherapy is indicated for the treatment of adults with:\n– advanced RET fusion-positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor. For biomarker-based patient selection, see section 4.2.\nRetsevmo as monotherapy is indicated for the treatment of adults and paediatric patients 2 years of age and older with:\n– advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate). For biomarker-based patient selection, see section 4.2.\n– advanced RET-mutant medullary thyroid cancer (MTC). For biomarker-based patient selection, see section 4.2.\n– advanced RET fusion-positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1). For biomarker-based patient selection, see section 4.2.","extracted":true,"target":{"targets":["RET","VEGFR1","VEGFR3","FGFR1","FGFR2","FGFR3"],"modality":"small molecule","label":"RET kinase inhibitor","mechanism":"Selpercatinib inhibits wild-type and mutant RET receptor tyrosine kinase isoforms and fusions, suppressing downstream oncogenic signalling and tumour cell proliferation.","quote":"Selpercatinib is an inhibitor of the rearranged during transfection (RET) receptor tyrosine kinase.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/retsevmo-epar-product-information_en.pdf"},"copies":[]},{"key":"lorlatinib__lorviqua","inn":"lorlatinib","brand":"Lorviqua","company":"Pfizer Europe MA EEIG","ema_product_number":"EMEA/H/C/004646","atc_code":"L01ED05","authorised":"2019-05-06","pi_updated":"2026-07-03","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lorviqua","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/lorviqua-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/lorviqua-epar-product-information_de.pdf","indication_text":"Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.\nLorviqua as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC whose disease has progressed after:\n• alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or\n• crizotinib and at least one other ALK TKI.","extracted":true,"target":{"targets":["ALK","ROS1"],"modality":"small molecule","label":"ALK and ROS1 inhibitor","mechanism":"Lorlatinib is an ATP-competitive tyrosine kinase inhibitor that selectively inhibits non-mutated ALK, clinically relevant ALK mutant kinases, and ROS1.","quote":"Lorlatinib is a selective, adenosine triphosphate (ATP)-competitive inhibitor of ALK and c-ros oncogene 1 (ROS1) tyrosine kinases.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/lorviqua-epar-product-information_en.pdf"},"copies":[]},{"key":"ipilimumab__yervoy","inn":"ipilimumab","brand":"Yervoy","company":"Bristol-Myers Squibb Pharma EEIG","ema_product_number":"EMEA/H/C/002213","atc_code":"L01FX04","authorised":"2011-07-13","pi_updated":"2026-06-24","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/yervoy","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/yervoy-epar-product-information_de.pdf","indication_text":"Melanoma\nYERVOY as monotherapy or in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4).\nRelative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1).\nRenal cell carcinoma (RCC)\nYERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1).\nNon-small cell lung cancer (NSCLC)\nYERVOY in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.\nMalignant pleural mesothelioma (MPM)\nYERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.\nMismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) YERVOY in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the following settings:\n- first-line treatment of unresectable or metastatic colorectal cancer;\n- treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy (see section 5.1).\nOesophageal squamous cell carcinoma (OSCC)\nYERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.\nHepatocellular carcinoma (HCC)\nYERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.","extracted":true,"target":{"targets":["CTLA-4"],"modality":"monoclonal antibody","label":"CTLA-4 immune checkpoint inhibitor","mechanism":"Ipilimumab blocks CTLA-4-induced inhibitory signals, increasing reactive T-effector cells and reducing regulatory T-cell function to drive an immune attack against tumour cells.","quote":"Ipilimumab is a CTLA-4 immune checkpoint inhibitor that blocks T-cell inhibitory signals induced by the CTLA-4 pathway, increasing the number of reactive T-effector cells which mobilize to mount a direct T-cell immune attack against tumour cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf"},"copies":[]},{"key":"erdafitinib__balversa","inn":"erdafitinib","brand":"Balversa","company":null,"ema_product_number":"EMEA/H/C/006050","atc_code":"L01EN01","authorised":"2024-08-22","pi_updated":"2026-06-23","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/balversa","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/balversa-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/balversa-epar-product-information_de.pdf","indication_text":"Balversa as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting (see section 5.1).","extracted":true,"target":{"targets":["FGFR"],"modality":"small molecule","label":"Pan-FGFR tyrosine kinase inhibitor","mechanism":"Erdafitinib acts as a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor.","quote":"Erdafitinib is a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/balversa-epar-product-information_en.pdf"},"copies":[]},{"key":"palbociclib__ibrance","inn":"palbociclib","brand":"Ibrance","company":"Pfizer Europe MA EEIG","ema_product_number":"EMEA/H/C/003853","atc_code":"L01EF01","authorised":"2016-11-09","pi_updated":"2025-03-07","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ibrance","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/ibrance-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/ibrance-epar-product-information_de.pdf","indication_text":"IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer:\n- in combination with an aromatase inhibitor;\n- in combination with fulvestrant in women who have received prior endocrine therapy (see section 5.1).\nIn pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.","extracted":true,"target":{"targets":["CDK4","CDK6"],"modality":"small molecule","label":"CDK4/6 inhibitor","mechanism":"Palbociclib is a selective, reversible inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6), which act downstream of multiple signalling pathways leading to cellular proliferation.","quote":"Palbociclib is a highly selective, reversible inhibitor of cyclin-dependent kinases (CDK) 4 and 6.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/ibrance-epar-product-information_en.pdf"},"copies":[{"brand":"Palbociclib Viatris","company":"Viatris Limited","kind":"generic","authorised":"2026-06-19","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/palbociclib-viatris"}]},{"key":"tarlatamab__imdylltra","inn":"tarlatamab","brand":"Imdylltra","company":"Amgen Europe B.V.","ema_product_number":"EMEA/H/C/006451","atc_code":"L01FX33","authorised":"2026-05-29","pi_updated":"2026-06-23","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/imdylltra","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/imdylltra-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/imdylltra-epar-product-information_de.pdf","indication_text":"IMDYLLTRA is indicated as monotherapy for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy.","extracted":true,"target":{"targets":["DLL3","CD3"],"modality":"bispecific antibody","label":"DLL3 × CD3 bispecific antibody","mechanism":"Binds DLL3 on tumor cells and CD3 on T cells, triggering T-cell activation and release of cytotoxic proteins to lyse DLL3-positive tumor cells.","quote":"Tarlatamab is a bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager that binds to DLL3 expressed on the surface of tumour cells and CD3 expressed on the surface of T-cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/imdylltra-epar-product-information_en.pdf"},"copies":[]},{"key":"nadofaragene-firadenovec__adstiladrin","inn":"nadofaragene firadenovec","brand":"Adstiladrin","company":"Ferring Pharmaceuticals A/S","ema_product_number":"EMEA/H/C/005856","atc_code":"L01XL10","authorised":"2026-05-28","pi_updated":"2026-06-23","conditional":true,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":true,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/adstiladrin","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/adstiladrin-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/adstiladrin-epar-product-information_de.pdf","indication_text":"ADSTILADRIN is indicated as monotherapy for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.","extracted":true,"target":{"targets":[],"modality":"other","label":"IFNα2b-expressing intravesical adenoviral gene therapy","mechanism":"A non-replicating adenovirus vector enters bladder tumour cells and urothelium, causing them to express IFNα2b protein without integrating into the genome; the text names no molecular target.","quote":"ADSTILADRIN is a non-replicating recombinant type 5 adenovirus vector-based gene therapy containing the human IFNα2b transgene.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/adstiladrin-epar-product-information_en.pdf"},"copies":[]},{"key":"trastuzumab-emtansine__kadcyla","inn":"trastuzumab emtansine","brand":"Kadcyla","company":"Roche Registration GmbH","ema_product_number":"EMEA/H/C/002389","atc_code":"L01FD03","authorised":"2013-11-15","pi_updated":"2026-06-16","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/kadcyla","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/kadcyla-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/kadcyla-epar-product-information_de.pdf","indication_text":"Early Breast Cancer (EBC)\nKadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.\nMetastatic Breast Cancer (MBC)\nKadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either:\n Received prior therapy for locally advanced or metastatic disease, or  Developed disease recurrence during or within six months of completing adjuvant therapy.","extracted":true,"target":{"targets":["HER2"],"modality":"antibody-drug conjugate","label":"HER2-directed antibody-drug conjugate","mechanism":"Binds HER2, undergoes internalisation to release the microtubule inhibitor DM1, which inhibits tubulin polymerisation, arresting cells in G2/M phase and inducing apoptosis.","quote":"Kadcyla, trastuzumab emtansine, is a HER2-targeted antibody-drug conjugate which contains the humanised anti-HER2 IgG1, trastuzumab, covalently linked to the microtubule inhibitor DM1 (a maytansine derivative) via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/kadcyla-epar-product-information_en.pdf"},"copies":[]},{"key":"zanidatamab__ziihera","inn":"zanidatamab","brand":"Ziihera","company":"Jazz Pharmaceuticals Ireland Limited","ema_product_number":"EMEA/H/C/006380","atc_code":"L01FD07","authorised":"2025-06-27","pi_updated":"2026-06-16","conditional":true,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ziihera","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/ziihera-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/ziihera-epar-product-information_de.pdf","indication_text":"Ziihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy (for biomarker-based patient selection, see section 4.2).","extracted":true,"target":{"targets":["HER2"],"modality":"bispecific antibody","label":"Dual HER2-targeted bispecific antibody","mechanism":"Binds extracellular domains 2 and 4 of HER2, inducing receptor internalization, CDC, ADCC, and ADCP to inhibit tumor growth and cause tumor cell death.","quote":"Zanidatamab is a dual HER2-targeted bispecific antibody that simultaneously binds extracellular domains 2 and 4 on separate HER2 monomers (binding in trans).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/ziihera-epar-product-information_en.pdf"},"copies":[]},{"key":"lenalidomide__revlimid","inn":"lenalidomide","brand":"Revlimid","company":"Bristol-Myers Squibb Pharma EEIG","ema_product_number":"EMEA/H/C/000717","atc_code":"L04AX04","authorised":"2007-06-14","pi_updated":"2025-09-09","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/revlimid","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/revlimid-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/revlimid-epar-product-information_de.pdf","indication_text":"Multiple myeloma\nRevlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.\nRevlimid as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.\nRevlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.\nMyelodysplastic syndromes\nRevlimid as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.\nMantle cell lymphoma\nRevlimid as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1).\nFollicular lymphoma\nRevlimid in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).","extracted":true,"target":{"targets":["CRBN","IKZF3","IKZF1"],"modality":"small molecule","label":"Immunomodulatory agent (cereblon modulator)","mechanism":"Binds cereblon in the CRL4 E3 ubiquitin ligase, recruiting Aiolos and Ikaros for ubiquitination and degradation, giving direct cytotoxic, immunomodulatory and anti-angiogenic effects.","quote":"Lenalidomide binds directly to cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex that includes deoxyribonucleic acid (DNA) damage-binding protein 1(DDB1), cullin 4 (CUL4), and regulator of cullins 1 (Roc1).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/revlimid-epar-product-information_en.pdf"},"copies":[{"brand":"Lenalidomide Mylan","company":"Mylan Pharmaceuticals Limited","kind":"generic","authorised":"2020-12-18","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lenalidomide-mylan"},{"brand":"Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto)","company":"Krka, d.d., Novo mesto ","kind":"generic","authorised":"2021-02-11","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lenalidomide-krka"},{"brand":"Lenalidomide Accord","company":"Accord Healthcare S.L.U.","kind":"generic","authorised":"2018-09-20","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lenalidomide-accord"},{"brand":"Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka)","company":"Krka, d.d., Novo mesto ","kind":"generic","authorised":"2021-02-11","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lenalidomide-krka-dd-novo-mesto"}]},{"key":"fulvestrant__faslodex","inn":"fulvestrant","brand":"Faslodex","company":"AstraZeneca AB","ema_product_number":"EMEA/H/C/000540","atc_code":"L02BA03","authorised":"2004-03-09","pi_updated":"2025-05-15","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/faslodex","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/faslodex-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/faslodex-epar-product-information_de.pdf","indication_text":"Faslodex is indicated:\n• as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:\n- not previously treated with endocrine therapy, or\n- with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy.\n• in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy (see section 5.1).\nIn pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.","extracted":true,"target":{"targets":["estrogen receptor"],"modality":"small molecule","label":"Selective estrogen receptor degrader","mechanism":"Competitive estrogen receptor antagonist that blocks the trophic actions of estrogens without partial agonist activity and downregulates estrogen receptor protein levels.","quote":"Fulvestrant is a competitive estrogen receptor (ER) antagonist with an affinity comparable to estradiol.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/faslodex-epar-product-information_en.pdf"},"copies":[{"brand":"Fulvestrant Mylan","company":"Mylan Pharmaceuticals Limited","kind":"generic","authorised":"2018-01-08","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/fulvestrant-mylan"}]},{"key":"nogapendekin-alfa-inbakicept__anktiva","inn":"nogapendekin alfa inbakicept","brand":"Anktiva","company":"Immunitybio Ireland Limited","ema_product_number":"EMEA/H/C/006622","atc_code":"L03AC03","authorised":"2026-02-16","pi_updated":"2026-06-12","conditional":true,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/anktiva","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/anktiva-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/anktiva-epar-product-information_de.pdf","indication_text":"ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.","extracted":true,"target":{"targets":["IL-15 receptor","IL-2/IL-15Rβ (CD122)","γc (CD132)"],"modality":"protein or peptide","label":"IL-15 receptor agonist","mechanism":"Binds the IL-15 receptor (shared IL-2/IL-15 βc/γc) to drive proliferation and activation of NK, CD4+, CD8+ and memory T cells without expanding immunosuppressive Treg cells.","quote":"Nogapendekin alfa inbakicept is an IL-15 receptor agonist.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/anktiva-epar-product-information_en.pdf"},"copies":[]},{"key":"niraparib__zejula","inn":"niraparib","brand":"Zejula","company":"GlaxoSmithKline Trading Services Limited","ema_product_number":"EMEA/H/C/004249","atc_code":"L01XK02","authorised":"2017-11-16","pi_updated":"2026-06-10","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zejula","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/zejula-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/zejula-epar-product-information_de.pdf","indication_text":"Zejula is indicated:\n• as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.\n• as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.","extracted":true,"target":{"targets":["PARP1","PARP2"],"modality":"small molecule","label":"PARP inhibitor","mechanism":"Inhibits PARP-1 and PARP-2 enzymes and increases formation of PARP-DNA complexes, leading to DNA damage, apoptosis, and cell death.","quote":"Niraparib is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, PARP-1 and PARP-2, which play a role in DNA repair.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/zejula-epar-product-information_en.pdf"},"copies":[]},{"key":"momelotinib__omjjara","inn":"momelotinib","brand":"Omjjara","company":"GlaxoSmithKline Trading Services Limited","ema_product_number":"EMEA/H/C/005768","atc_code":"","authorised":"2024-01-25","pi_updated":"2026-06-08","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/omjjara","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/omjjara-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/omjjara-epar-product-information_de.pdf","indication_text":"Omjjara is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.","extracted":true,"target":{"targets":["JAK1","JAK2","ACVR1"],"modality":"small molecule","label":"JAK1/JAK2 and ACVR1 inhibitor","mechanism":"Inhibits JAK1, JAK2 (including mutant JAK2 V617F) and STAT signalling, and directly inhibits ACVR1, lowering hepcidin and increasing iron availability and red blood cell production.","quote":"Momelotinib and its major human circulating metabolite (M21), are inhibitors of wild type Janus Kinase 1 and 2 (JAK1/JAK2) and mutant JAK2V617F, which contribute to signalling of a number of cytokines and growth factors that are important for haematopoiesis and immune function.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/omjjara-epar-product-information_en.pdf"},"copies":[]},{"key":"axicabtagene-ciloleucel__yescarta","inn":"axicabtagene ciloleucel","brand":"Yescarta","company":"Kite Pharma EU B.V.","ema_product_number":"EMEA/H/C/004480","atc_code":"L01XX70","authorised":"2018-08-23","pi_updated":"2026-06-08","conditional":false,"exceptional":false,"orphan":true,"prime":true,"advanced_therapy":true,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/yescarta","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/yescarta-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/yescarta-epar-product-information_de.pdf","indication_text":"Yescarta is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.\nYescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) DLBCL and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.\nYescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (FL) after three or more lines of systemic therapy.","extracted":true,"target":{"targets":["CD19"],"modality":"cell therapy","label":"CD19-directed CAR T-cell therapy","mechanism":"Engineered autologous T cells bind CD19-expressing target cells, triggering activation, proliferation, and cytokine release, resulting in apoptosis and necrosis of target cells.","quote":"Yescarta, an engineered autologous T-cell immunotherapy product, binds to CD19 expressing cancer cells and normal B-cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/yescarta-epar-product-information_en.pdf"},"copies":[]},{"key":"alectinib__alecensa","inn":"alectinib","brand":"Alecensa","company":"Roche Registration GmbH","ema_product_number":"EMEA/H/C/004164","atc_code":"L01ED03","authorised":"2017-02-16","pi_updated":"2026-03-31","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/alecensa","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/alecensa-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/alecensa-epar-product-information_de.pdf","indication_text":"Adjuvant treatment of resected non-small cell lung cancer (NSCLC)\nAlecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for adult patients with ALK-positive NSCLC at high risk of recurrence (see section 5.1 for selection criteria).\nTreatment of advanced NSCLC\nAlecensa as monotherapy is indicated for the first-line treatment of adult patients with ALK-positive advanced NSCLC.\nAlecensa as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.","extracted":true,"target":{"targets":["ALK","RET"],"modality":"small molecule","label":"ALK and RET kinase inhibitor","mechanism":"Alectinib selectively inhibits ALK and RET tyrosine kinases, blocking downstream STAT3 and PI3K/AKT signalling pathways and inducing tumour cell death.","quote":"Alectinib is a highly selective and potent ALK and rearranged during transfection (RET) tyrosine kinase inhibitor.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/alecensa-epar-product-information_en.pdf"},"copies":[]},{"key":"tisotumab-vedotin__tivdak","inn":"tisotumab vedotin","brand":"Tivdak","company":"Genmab A/S","ema_product_number":"EMEA/H/C/005363","atc_code":"L01FX23","authorised":"2025-03-28","pi_updated":"2026-06-05","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tivdak","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/tivdak-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/tivdak-epar-product-information_de.pdf","indication_text":"Tivdak as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy (see section 5.1).","extracted":true,"target":{"targets":["TF"],"modality":"antibody-drug conjugate","label":"TF-directed antibody-drug conjugate (MMAE)","mechanism":"Binds tissue factor (TF) on tumour cells and is internalised, then releases MMAE, which disrupts microtubules and causes cell-cycle arrest and apoptotic cell death.","quote":"Tisotumab vedotin is an antibody-drug conjugate (ADC) directed to tissue factor (TF), a cell surface protein expressed at elevated levels on a variety of solid tumours relative to normal tissue.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/tivdak-epar-product-information_en.pdf"},"copies":[]},{"key":"lurbinectedin__zepzelca","inn":"lurbinectedin","brand":"Zepzelca","company":"Pharma Mar S.A.","ema_product_number":"EMEA/H/C/006673","atc_code":"L01XX69","authorised":"2026-05-29","pi_updated":"2026-06-01","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zepzelca","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/zepzelca-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/zepzelca-epar-product-information_de.pdf","indication_text":"ZEPZELCA, in combination with atezolizumab, is indicated for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.","extracted":true,"target":{"targets":["DNA (CG-rich promoter sequences)"],"modality":"small molecule","label":"DNA-binding transcription inhibitor","mechanism":"Binds CG-rich DNA sequences in gene promoters, evicts oncogenic transcription factors and stalls elongating RNA polymerase II, causing its degradation, cell cycle arrest and tumour cell apoptosis.","quote":"Lurbinectedin inhibits the oncogenic transcription process through (i) its binding to CG-rich sequences of DNA, located within promoters of protein-coding genes; (ii) the eviction of oncogenic transcription factors from their binding sites; and (iii) the stalling of elongating RNA polymerase II and its specific degradation by the ubiquitin/proteasome machinery with all these processes leading to subsequent cell cycle arrest and tumour cell apoptosis.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/zepzelca-epar-product-information_en.pdf"},"copies":[]},{"key":"trametinib__mekinist","inn":"trametinib","brand":"Mekinist","company":"Novartis Europharm Limited","ema_product_number":"EMEA/H/C/002643","atc_code":"L01EE01","authorised":"2014-06-30","pi_updated":"2026-05-22","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/mekinist","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/mekinist-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/mekinist-epar-product-information_de.pdf","indication_text":"Melanoma\nTrametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).\nTrametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see section 5.1).\nAdjuvant treatment of melanoma\nTrametinib in combination with dabrafenib is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection.\nNon-small cell lung cancer (NSCLC)\nTrametinib in combination with dabrafenib is indicated for the treatment of adults with advanced non-small cell lung cancer with a BRAF V600 mutation.\nDifferentiated thyroid cancer (DTC)\nTrametinib in combination with dabrafenib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2).","extracted":true,"target":{"targets":["MEK1/2"],"modality":"small molecule","label":"MEK1/2 inhibitor","mechanism":"Reversible, highly selective allosteric inhibitor of MEK1 and MEK2 activation and kinase activity, blocking BRAF-driven signalling through the ERK pathway.","quote":"Trametinib is a reversible, highly selective, allosteric inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2 activation and kinase activity.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/mekinist-epar-product-information_en.pdf"},"copies":[]},{"key":"trametinib__spexotras","inn":"trametinib","brand":"Spexotras","company":"Novartis Europharm Limited","ema_product_number":"EMEA/H/C/005886","atc_code":"L01EE01","authorised":"2024-01-05","pi_updated":"2026-05-19","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/spexotras","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/spexotras-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/spexotras-epar-product-information_de.pdf","indication_text":"Low-grade glioma\nSpexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.\nHigh-grade glioma\nSpexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.","extracted":true,"target":{"targets":["MEK1/2"],"modality":"small molecule","label":"MEK1/2 inhibitor","mechanism":"Trametinib reversibly and allosterically inhibits MEK1 and MEK2 activation by BRAF and their kinase activity, blocking ERK pathway signalling; it is used with the RAF inhibitor dabrafenib.","quote":"Trametinib is a reversible, highly selective, allosteric inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2 activation and kinase activity.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/spexotras-epar-product-information_en.pdf"},"copies":[]},{"key":"brexucabtagene-autoleucel__tecartus","inn":"brexucabtagene autoleucel","brand":"Tecartus","company":"Kite Pharma EU B.V.","ema_product_number":"EMEA/H/C/005102","atc_code":"L01X","authorised":"2020-12-14","pi_updated":"2026-05-19","conditional":true,"exceptional":false,"orphan":true,"prime":true,"advanced_therapy":true,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tecartus","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/tecartus-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/tecartus-epar-product-information_de.pdf","indication_text":"Mantle cell lymphoma\nTecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.\nAcute lymphoblastic leukaemia\nTecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).","extracted":true,"target":{"targets":["CD19"],"modality":"cell therapy","label":"CD19-directed CAR T-cell therapy","mechanism":"Binds to CD19-expressing cancer and normal B cells, activating intracellular signaling that induces T-cell proliferation, effector functions, and killing of target cells.","quote":"Tecartus, a CD19-directed genetically modified autologous T-cell immunotherapy, binds to CD19 expressing cancer cells and normal B cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/tecartus-epar-product-information_en.pdf"},"copies":[]},{"key":"dabrafenib__tafinlar","inn":"dabrafenib","brand":"Tafinlar","company":"Novartis Europharm Limited","ema_product_number":"EMEA/H/C/002604","atc_code":"L01EC02","authorised":"2013-08-26","pi_updated":"2026-05-19","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tafinlar","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/tafinlar-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/tafinlar-epar-product-information_de.pdf","indication_text":"Melanoma\nDabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).\nAdjuvant treatment of melanoma\nDabrafenib in combination with trametinib is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection.\nNon-small cell lung cancer (NSCLC)\nDabrafenib in combination with trametinib is indicated for the treatment of adults with advanced non-small cell lung cancer with a BRAF V600 mutation.\nDifferentiated thyroid cancer (DTC)\nDabrafenib in combination with trametinib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2).","extracted":true,"target":{"targets":["BRAF","CRAF"],"modality":"small molecule","label":"BRAF inhibitor","mechanism":"Dabrafenib inhibits RAF kinases, particularly BRAF with activating V600 mutations, suppressing ERK phosphorylation in the RAS/RAF/MEK/ERK pathway and inhibiting tumour cell growth.","quote":"Dabrafenib is an inhibitor of RAF kinases.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/tafinlar-epar-product-information_en.pdf"},"copies":[]},{"key":"dabrafenib__finlee","inn":"dabrafenib","brand":"Finlee","company":"Novartis Europharm Limited","ema_product_number":"EMEA/H/C/005885","atc_code":"L01EC02","authorised":"2023-11-15","pi_updated":"2026-03-30","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/finlee","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/finlee-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/finlee-epar-product-information_de.pdf","indication_text":"Low-grade glioma\nFinlee in combination with trametinib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.\nHigh-grade glioma\nFinlee in combination with trametinib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.","extracted":true,"target":{"targets":["BRAF"],"modality":"small molecule","label":"BRAF inhibitor","mechanism":"Dabrafenib inhibits RAF kinases, including mutant BRAF V600, blocking constitutive RAS/RAF/MEK/ERK signalling; it is used with the MEK inhibitor trametinib for dual pathway blockade.","quote":"Dabrafenib is an inhibitor of RAF kinases.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/finlee-epar-product-information_en.pdf"},"copies":[]},{"key":"inotuzumab-ozogamicin__besponsa","inn":"inotuzumab ozogamicin","brand":"Besponsa","company":"Pfizer Europe MA EEIG","ema_product_number":"EMEA/H/C/004119","atc_code":"L01FB01","authorised":"2017-06-28","pi_updated":"2026-05-18","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/besponsa","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/besponsa-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/besponsa-epar-product-information_de.pdf","indication_text":"BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B-cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI).\nBESPONSA is indicated as monotherapy for paediatric patients 1 year and older with CD22-positive B-cell precursor ALL: in first relapse after allo-haematopoietic stem cell transplant (HSCT); after any first relapse in patients with Very High Risk (VHR) disease (see section 5.1); after a second or greater relapse; and in those with refractory disease. Patients with Philadelphia chromosome positive (Ph+) disease should have exhausted relevant BCR-ABL targeting treatment options.","extracted":true,"target":{"targets":["CD22"],"modality":"antibody-drug conjugate","label":"CD22-directed antibody-drug conjugate","mechanism":"Binds CD22-expressing tumour cells and internalises to intracellularly release calicheamicin, which induces double-stranded DNA breaks and apoptotic cell death.","quote":"Inotuzumab ozogamicin is an ADC composed of a CD22-directed monoclonal antibody that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/besponsa-epar-product-information_en.pdf"},"copies":[]},{"key":"afatinib__giotrif","inn":"afatinib","brand":"Giotrif","company":"Boehringer Ingelheim International GmbH","ema_product_number":"EMEA/H/C/002280","atc_code":"L01XE13","authorised":"2013-09-25","pi_updated":"2026-05-11","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/giotrif","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/giotrif-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/giotrif-epar-product-information_de.pdf","indication_text":"GIOTRIF as monotherapy is indicated for the treatment of\n• Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s);\n• Adult patients with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy (see section 5.1).","extracted":true,"target":{"targets":["EGFR","HER2","ErbB3","ErbB4"],"modality":"small molecule","label":"Irreversible ErbB family inhibitor","mechanism":"Afatinib covalently binds to and irreversibly blocks signalling from homo- and heterodimers formed by ErbB family members EGFR, HER2, ErbB3, and ErbB4.","quote":"Afatinib covalently binds to and irreversibly blocks signalling from all homo- and heterodimers formed by the ErbB family members EGFR (ErbB1), HER2 (ErbB2), ErbB3 and ErbB4.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/giotrif-epar-product-information_en.pdf"},"copies":[]},{"key":"tovorafenib__ojemda","inn":"tovorafenib","brand":"Ojemda","company":"Ipsen Pharma","ema_product_number":"EMEA/H/C/006140","atc_code":"L01EC04","authorised":"2026-04-20","pi_updated":"2026-05-11","conditional":true,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ojemda","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/ojemda-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/ojemda-epar-product-information_de.pdf","indication_text":"Ojemda is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low-grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies (for biomarkers-based patient selection, see section 4.2).","extracted":true,"target":{"targets":["BRAF","CRAF"],"modality":"small molecule","label":"Type II RAF kinase inhibitor","mechanism":"CNS-penetrant Type II RAF inhibitor of mutant BRAF V600E, wild-type BRAF and CRAF (monomers, dimers and BRAF fusions), suppressing MAPK pathway activation.","quote":"Tovorafenib is a central nervous system (CNS) penetrant, selective small molecule Type II RAF kinase inhibitor of mutant BRAF V600E, wild-type BRAF, and wild-type CRAF kinases, including RAF monomers and dimers and BRAF fusion, suppressing activation of the mitogen-activated protein kinase (MAPK) pathway (see section 5.3).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/ojemda-epar-product-information_en.pdf"},"copies":[]},{"key":"inavolisib__itovebi","inn":"inavolisib","brand":"Itovebi","company":"Roche Registration GmbH ","ema_product_number":"EMEA/H/C/006353","atc_code":"","authorised":"2025-07-18","pi_updated":"2026-05-08","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/itovebi","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/itovebi-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/itovebi-epar-product-information_de.pdf","indication_text":"Itovebi, in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment (see section 5.1).\nPatients previously treated with a CDK 4/6 inhibitor in the (neo)adjuvant setting should have had an interval of at least 12 months between termination of CDK 4/6 inhibitor treatment and the detection of recurrence.\nIn pre/perimenopausal women and in men, endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.","extracted":true,"target":{"targets":["PI3Kα"],"modality":"small molecule","label":"PI3Kα inhibitor and mutant degrader","mechanism":"Inavolisib inhibits the PI3K catalytic subunit alpha (p110α) and degrades mutated p110α, reducing downstream PI3K/AKT signalling, cell proliferation and survival.","quote":"Inavolisib is an inhibitor of the phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3K) catalytic subunit alpha isoform protein (p110α; encoded by the PIK3CA gene).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/itovebi-epar-product-information_en.pdf"},"copies":[]},{"key":"catumaxomab__korjuny","inn":"catumaxomab","brand":"Korjuny","company":"Atnahs Pharma Netherlands B.V.","ema_product_number":"EMEA/H/C/005697","atc_code":"L01FX03","authorised":"2025-02-10","pi_updated":"2026-05-06","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/korjuny","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/korjuny-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/korjuny-epar-product-information_de.pdf","indication_text":"Korjuny is indicated for the intraperitoneal treatment of malignant ascites in adults with epithelial cellular adhesion molecule (EpCAM)-positive carcinomas, who are not eligible for further systemic anticancer therapy.","extracted":true,"target":{"targets":["EpCAM","CD3"],"modality":"bispecific antibody","label":"EpCAM × CD3 bispecific trifunctional antibody","mechanism":"Binds EpCAM on tumour cells and CD3 on T cells, and engages accessory immune cells via its Fc region, bringing them together to kill tumour cells (T-cell killing, ADCC, CDC, phagocytosis).","quote":"Catumaxomab is a trifunctional rat-mouse hybrid monoclonal antibody that is specifically directed against the epithelial cell adhesion molecule (EpCAM) and the CD3 antigen.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/korjuny-epar-product-information_en.pdf"},"copies":[]},{"key":"capivasertib__truqap","inn":"capivasertib","brand":"Truqap","company":"AstraZeneca AB","ema_product_number":"EMEA/H/C/006017","atc_code":"L01EX27","authorised":"2024-06-17","pi_updated":"2026-05-06","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/truqap","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/truqap-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/truqap-epar-product-information_de.pdf","indication_text":"TRUQAP is indicated in combination with fulvestrant for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen (see section 5.1).\nIn pre- or perimenopausal women, TRUQAP plus fulvestrant should be combined with a luteinising hormone releasing hormone (LHRH) agonist.\nFor men, administration of LHRH agonist according to current clinical practice standards should be considered.","extracted":true,"target":{"targets":["AKT1","AKT2","AKT3"],"modality":"small molecule","label":"Pan-AKT inhibitor","mechanism":"Capivasertib selectively inhibits the kinase activity of all three AKT isoforms (AKT1, AKT2, AKT3), inhibiting downstream signalling involved in tumour cell survival and proliferation.","quote":"Capivasertib is a potent, selective inhibitor of the kinase activity of all 3 isoforms of serine/threonine kinase AKT (AKT1, AKT2 and AKT3).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/truqap-epar-product-information_en.pdf"},"copies":[]},{"key":"apalutamide__erleada","inn":"apalutamide","brand":"Erleada","company":"Janssen-Cilag International NV","ema_product_number":"EMEA/H/C/004452","atc_code":"L02BB05","authorised":"2019-01-14","pi_updated":"2026-04-22","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/erleada","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/erleada-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/erleada-epar-product-information_de.pdf","indication_text":"Erleada is indicated:\n in adult men for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1).\n in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT) (see section 5.1).","extracted":true,"target":{"targets":["androgen receptor"],"modality":"small molecule","label":"Selective androgen receptor inhibitor","mechanism":"Binds the androgen receptor ligand-binding domain, preventing AR nuclear translocation, DNA binding and AR-mediated transcription, with no agonist activity; reduces tumour proliferation and increases apoptosis.","quote":"Apalutamide is an orally administered, selective Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/erleada-epar-product-information_en.pdf"},"copies":[]},{"key":"sorafenib__nexavar","inn":"sorafenib","brand":"Nexavar","company":"Bayer AG","ema_product_number":"EMEA/H/C/000690","atc_code":"L01EX02","authorised":"2006-07-19","pi_updated":"2025-03-28","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/nexavar","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/nexavar-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/nexavar-epar-product-information_de.pdf","indication_text":"Hepatocellular carcinoma\nNexavar is indicated for the treatment of hepatocellular carcinoma (see section 5.1).\nRenal cell carcinoma\nNexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.\nDifferentiated thyroid carcinoma\nNexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.","extracted":true,"target":{"targets":["CRAF","BRAF","VEGFR2","VEGFR3","PDGFRB","KIT"],"modality":"small molecule","label":"Multikinase inhibitor (RAF, VEGFR, PDGFR)","mechanism":"Sorafenib inhibits RAF serine/threonine kinases (CRAF, BRAF incl. V600E) and receptor tyrosine kinases (KIT, FLT3, VEGFR-2/3, PDGFR-β), reducing tumour-cell proliferation and tumour angiogenesis.","quote":"Sorafenib inhibits the activity of targets present in the tumour cell (CRAF, BRAF, V600E BRAF, c-KIT, and FLT-3) and in the tumour vasculature (CRAF, VEGFR-2, VEGFR-3, and PDGFR-ß).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/nexavar-epar-product-information_en.pdf"},"copies":[{"brand":"Sorafenib Accord","company":"Accord Healthcare S.L.U.","kind":"generic","authorised":"2022-11-09","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/sorafenib-accord"}]},{"key":"lenvatinib__kisplyx","inn":"lenvatinib","brand":"Kisplyx","company":"Eisai GmbH","ema_product_number":"EMEA/H/C/004224","atc_code":"L01XE29","authorised":"2016-08-25","pi_updated":"2026-03-26","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/kisplyx","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/kisplyx-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/kisplyx-epar-product-information_de.pdf","indication_text":"Kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (RCC):\n in combination with pembrolizumab, as first-line treatment (see section 5.1).\n in combination with everolimus, following one prior vascular endothelial growth factor (VEGF)-targeted therapy (see section 5.1).","extracted":true,"target":{"targets":["VEGFR1","VEGFR2","VEGFR3","FGFR1-4","PDGFRA","KIT"],"modality":"small molecule","label":"Multikinase inhibitor (VEGFR, FGFR, PDGFRα, KIT, RET)","mechanism":"Small-molecule RTK inhibitor that blocks the kinase activity of VEGFR1–3 and also FGFR1–4, PDGFRα, KIT and RET, suppressing proangiogenic and oncogenic signalling.","quote":"Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4), in addition to other proangiogenic and oncogenic pathway-related RTKs including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4, the platelet derived growth factor (PDGF) receptor PDGFRα, KIT, and RET.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/kisplyx-epar-product-information_en.pdf"},"copies":[]},{"key":"lenvatinib__lenvima","inn":"lenvatinib","brand":"Lenvima","company":"Eisai GmbH","ema_product_number":"EMEA/H/C/003727","atc_code":"L01XE","authorised":"2015-05-28","pi_updated":"2026-03-26","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lenvima","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/lenvima-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/lenvima-epar-product-information_de.pdf","indication_text":"Differentiated Thyroid Carcinoma (DTC)\nLENVIMA as monotherapy is indicated for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).\nHepatocellular Carcinoma (HCC)\nLENVIMA as monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy (see section 5.1).\nEndometrial Carcinoma (EC)\nLENVIMA in combination with pembrolizumab is indicated for the treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery or radiation.","extracted":true,"target":{"targets":["VEGFR1","VEGFR2","VEGFR3","FGFR1","FGFR2","FGFR3"],"modality":"small molecule","label":"Multikinase inhibitor (VEGFR, FGFR, PDGFRα, KIT, RET)","mechanism":"Small-molecule inhibitor of VEGFR1–3 kinases and other proangiogenic and oncogenic RTKs (FGFR1–4, PDGFRα, KIT, RET), blocking tumour angiogenesis and FGFR-driven proliferation.","quote":"Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4), in addition to other proangiogenic and oncogenic pathway-related RTKs including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4, the platelet derived growth factor (PDGF) receptor PDGFRα, KIT, and RET.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/lenvima-epar-product-information_en.pdf"},"copies":[]},{"key":"bortezomib__velcade","inn":"bortezomib","brand":"Velcade","company":"Janssen-Cilag International NV","ema_product_number":"EMEA/H/C/000539","atc_code":"L01XG01","authorised":"2004-04-26","pi_updated":"2024-10-18","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/velcade","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/velcade-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/velcade-epar-product-information_de.pdf","indication_text":"VELCADE as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.\nVELCADE in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.\nVELCADE in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.\nVELCADE in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.","extracted":true,"target":{"targets":["26S proteasome"],"modality":"small molecule","label":"Proteasome inhibitor","mechanism":"Reversibly inhibits the chymotrypsin-like activity of the 26S proteasome, disrupting protein turnover and inducing cell cycle arrest and apoptosis.","quote":"It is specifically designed to inhibit the chymotrypsin-like activity of the 26S proteasome in mammalian cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/velcade-epar-product-information_en.pdf"},"copies":[{"brand":"Bortezomib Accord","company":"Accord Healthcare S.L.U.","kind":"generic","authorised":"2015-07-20","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/bortezomib-accord"},{"brand":"Bortezomib Sun","company":"SUN Pharmaceutical Industries (Europe) B.V.","kind":"generic","authorised":"2016-07-22","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/bortezomib-sun"},{"brand":"Bortezomib Fresenius Kabi","company":"Fresenius Kabi Deutschland GmbH","kind":"generic","authorised":"2019-11-14","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/bortezomib-fresenius-kabi"}]},{"key":"regorafenib__stivarga","inn":"regorafenib","brand":"Stivarga","company":"Bayer Pharma AG","ema_product_number":"EMEA/H/C/002573","atc_code":"L01EX05","authorised":"2013-08-26","pi_updated":"2026-03-24","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/stivarga","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/stivarga-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/stivarga-epar-product-information_de.pdf","indication_text":"Stivarga is indicated as monotherapy for the treatment of adult patients with\n- metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy (see section 5.1)\n- unresectable or metastatic gastrointestinal stromal tumours (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib\n- hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.","extracted":true,"target":{"targets":["VEGFR1","VEGFR2","VEGFR3","TIE2","KIT","RET"],"modality":"small molecule","label":"Multikinase inhibitor (VEGFR, TIE2, KIT, RET)","mechanism":"Oral multikinase inhibitor blocking angiogenic (VEGFR1-3, TIE2), oncogenic (KIT, RET, RAF), metastatic (PDGFR, FGFR) and immune (CSF1R) kinases; inhibits mutated KIT to block tumour-cell proliferation.","quote":"Regorafenib is an oral tumour deactivation agent that potently blocks multiple protein kinases, including kinases involved in tumour angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF, BRAFV600E), metastasis (VEGFR3, PDGFR, FGFR) and tumour immunity (CSF1R).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/stivarga-epar-product-information_en.pdf"},"copies":[]},{"key":"retifanlimab__zynyz","inn":"retifanlimab","brand":"Zynyz","company":"Incyte Biosciences Distribution B.V.","ema_product_number":"EMEA/H/C/006194","atc_code":"L01FF10","authorised":"2024-04-19","pi_updated":"2026-03-18","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zynyz","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/zynyz-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/zynyz-epar-product-information_de.pdf","indication_text":"Squamous cell carcinoma of the anal canal (SCAC)\nZYNYZ is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC).\nMerkel cell carcinoma (MCC)\nZYNYZ is indicated as monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) not amenable to curative surgery or radiation therapy.","extracted":true,"target":{"targets":["PD-1"],"modality":"monoclonal antibody","label":"PD-1 inhibitor (antibody)","mechanism":"Retifanlimab is a monoclonal antibody that binds the PD-1 receptor and blocks interaction with PD-L1 and PD-L2, potentiating T-cell anti-tumour activity.","quote":"Retifanlimab is an immunoglobulin G4 (IgG4) monoclonal antibody that binds to the programmed death receptor-1 (PD-1) and blocks its interaction with its ligands PD-L1 and PD-L2.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/zynyz-epar-product-information_en.pdf"},"copies":[]},{"key":"brentuximab-vedotin__adcetris","inn":"brentuximab vedotin","brand":"Adcetris","company":"Takeda Pharma A/S","ema_product_number":"EMEA/H/C/002455","atc_code":"L01FX05","authorised":"2012-10-25","pi_updated":"2026-03-20","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/adcetris","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/adcetris-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/adcetris-epar-product-information_de.pdf","indication_text":"Hodgkin lymphoma\nADCETRIS is indicated for adult patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD) (see sections 4.2 and 5.1).\nADCETRIS is indicated for adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV HL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD) (see sections 4.2 and 5.1).\nADCETRIS is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT) (see section 5.1).\nADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):\n1. following ASCT, or 2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.\nSystemic anaplastic large cell lymphoma\nADCETRIS in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) (see section 5.1).\nADCETRIS is indicated for the treatment of adult patients with relapsed or refractory sALCL.\nCutaneous T-cell lymphoma\nADCETRIS is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy (see section 5.1).","extracted":true,"target":{"targets":["CD30"],"modality":"antibody-drug conjugate","label":"CD30-directed antibody-drug conjugate","mechanism":"Binds CD30, internalises, and releases MMAE to disrupt the microtubule network via tubulin binding, leading to cell cycle arrest and apoptosis.","quote":"Brentuximab vedotin is an ADC that delivers an antineoplastic agent that results in apoptotic cell death selectively in CD30-expressing tumour cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/adcetris-epar-product-information_en.pdf"},"copies":[]},{"key":"obinutuzumab__gazyvaro","inn":"obinutuzumab","brand":"Gazyvaro","company":"Roche Registration GmbH","ema_product_number":"EMEA/H/C/002799","atc_code":"L01FA03","authorised":"2014-07-22","pi_updated":"2026-03-17","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/gazyvaro","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/gazyvaro-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/gazyvaro-epar-product-information_de.pdf","indication_text":"Chronic lymphocytic leukaemia (CLL)\nGazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated CLL and with comorbidities making them unsuitable for full-dose fludarabine based therapy (see section 5.1).\nFollicular lymphoma (FL)\nGazyvaro in combination with chemotherapy followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced FL (see section 5.1) Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.\nLupus nephritis (LN)\nGazyvaro in combination with mycophenolate mofetil (MMF) is indicated for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis (LN).","extracted":true,"target":{"targets":["CD20"],"modality":"monoclonal antibody","label":"Anti-CD20 monoclonal antibody","mechanism":"Binds to CD20 on B-lymphocytes to induce direct cell death and mediate enhanced ADCC and ADCP via FcγRIII-bearing effector cells, leading to potent B-cell depletion.","quote":"It specifically targets the extracellular loop of the CD20 transmembrane antigen on the surface of non-malignant and malignant pre-B and mature B-lymphocytes, but not on haematopoietic stem cells, pro-B-cells, normal plasma cells or other normal tissue.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/gazyvaro-epar-product-information_en.pdf"},"copies":[]},{"key":"pemigatinib__pemazyre","inn":"pemigatinib","brand":"Pemazyre","company":"Incyte Biosciences Distribution B.V.","ema_product_number":"EMEA/H/C/005266","atc_code":"L01EN02","authorised":"2021-03-26","pi_updated":"2026-03-17","conditional":true,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/pemazyre","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/pemazyre-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/pemazyre-epar-product-information_de.pdf","indication_text":"Pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.","extracted":true,"target":{"targets":["FGFR1","FGFR2","FGFR3"],"modality":"small molecule","label":"FGFR kinase inhibitor","mechanism":"Inhibits FGFR1, 2, and 3 phosphorylation and signalling, decreasing cell viability in cells expressing FGFR genetic alterations.","quote":"Pemigatinib is a kinase inhibitor of FGFR1, 2 and 3 which inhibits FGFR phosphorylation and signalling and decreases cell viability in cells expressing FGFR genetic alterations, including point mutations, amplifications, and fusions or rearrangements.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/pemazyre-epar-product-information_en.pdf"},"copies":[]},{"key":"ivosidenib__tibsovo","inn":"ivosidenib","brand":"Tibsovo","company":"Les Laboratoires Servier","ema_product_number":"EMEA/H/C/005936","atc_code":"L01XM02","authorised":"2023-05-04","pi_updated":"2026-02-25","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tibsovo","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/tibsovo-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/tibsovo-epar-product-information_de.pdf","indication_text":"Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy (see section 5.1).\nTibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy (see section 5.1).","extracted":true,"target":{"targets":["IDH1"],"modality":"small molecule","label":"Mutant IDH1 inhibitor","mechanism":"Ivosidenib inhibits the mutant IDH1 enzyme, reducing 2-hydroxyglutarate levels and restoring cellular differentiation.","quote":"Ivosidenib is an inhibitor of the mutant IDH1 enzyme.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/tibsovo-epar-product-information_en.pdf"},"copies":[]},{"key":"imlunestrant__inluriyo","inn":"imlunestrant","brand":"Inluriyo","company":"Eli Lilly Nederland B.V.","ema_product_number":"EMEA/H/C/006184","atc_code":"L02BA","authorised":"2026-01-09","pi_updated":"2026-02-23","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/inluriyo","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/inluriyo-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/inluriyo-epar-product-information_de.pdf","indication_text":"Inluriyo is indicated as monotherapy for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1-mutation, who have disease progression following prior treatment with an endocrine based regimen (for biomarker-based patient selection, see section 4.2).\nIn pre- or perimenopausal women, or men, Inluriyo should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.","extracted":true,"target":{"targets":["ERα"],"modality":"small molecule","label":"Selective estrogen receptor degrader","mechanism":"Imlunestrant antagonises and degrades wild-type and mutant ERα, inhibiting oestrogen receptor-dependent gene transcription and cell proliferation in ER-positive breast cancer cells.","quote":"Imlunestrant is an antagonist and degrader of wild-type and mutant oestrogen receptor-α (ERα), leading to inhibition of oestrogen receptor-dependent gene transcription and cellular proliferation in ER-positive breast cancer cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/inluriyo-epar-product-information_en.pdf"},"copies":[]},{"key":"tremelimumab__imjudo","inn":"tremelimumab","brand":"Imjudo","company":"AstraZeneca AB","ema_product_number":"EMEA/H/C/006016","atc_code":"L01FX20","authorised":"2023-02-20","pi_updated":"2025-08-14","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/imjudo","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/imjudo-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/imjudo-epar-product-information_de.pdf","indication_text":"IMJUDO in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).\nIMJUDO in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.","extracted":true,"target":{"targets":["CTLA-4"],"modality":"monoclonal antibody","label":"CTLA-4 inhibitor (antibody)","mechanism":"Tremelimumab is a monoclonal antibody that blocks CTLA-4 interaction with CD80 and CD86, enhancing T-cell activation and anti-tumour activity.","quote":"Tremelimumab is a selective, fully human IgG2 antibody that blocks CTLA-4 interaction with CD80 and CD86, thus enhancing T-cell activation and proliferation, resulting in increased T-cell diversity and enhanced anti-tumour activity.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/imjudo-epar-product-information_en.pdf"},"copies":[]},{"key":"vimseltinib__romvimza","inn":"vimseltinib","brand":"Romvimza","company":"Deciphera Pharmaceuticals (Netherlands) B.V.","ema_product_number":"EMEA/H/C/006363","atc_code":"L01EX","authorised":"2025-09-17","pi_updated":"2026-02-11","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/romvimza","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/romvimza-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/romvimza-epar-product-information_de.pdf","indication_text":"ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumour (TGCT) associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability.","extracted":true,"target":{"targets":["CSF1R"],"modality":"small molecule","label":"CSF1R kinase inhibitor","mechanism":"Vimseltinib inhibits CSF1R autophosphorylation and downstream signalling, depleting CSF1R-dependent macrophages and inflammatory cells to exert anti-tumour effects.","quote":"Vimseltinib is a selective small molecule tyrosine kinase inhibitor that targets colony stimulating factor 1 receptor (CSF1R).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/romvimza-epar-product-information_en.pdf"},"copies":[]},{"key":"dasatinib__dasatinib-accord-healthcare","inn":"dasatinib","brand":"Dasatinib Accord Healthcare","company":"Accord Healthcare S.L.U.","ema_product_number":"EMEA/H/C/006251","atc_code":"L01EA02","authorised":"2024-07-26","pi_updated":"2026-02-05","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":true,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/dasatinib-accord-healthcare","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/dasatinib-accord-healthcare-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/dasatinib-accord-healthcare-epar-product-information_de.pdf","indication_text":"Dasatinib Accord Healthcare is indicated for the treatment of adult patients with:\n▪ newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase.\n▪ chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib.\n▪ Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.\nDasatinib Accord Healthcare is indicated for the treatment of paediatric patients with:\n▪ newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.\n▪ newly diagnosed Ph+ ALL in combination with chemotherapy.","extracted":true,"target":{"targets":["BCR-ABL","SRC family kinases","LYN","HCK"],"modality":"small molecule","label":"BCR-ABL/SRC kinase inhibitor","mechanism":"Dasatinib inhibits SRC family kinases (incl. LYN, HCK) at subnanomolar levels and acts against BCR-ABL-driven leukaemic cells, overcoming several mechanisms of imatinib resistance.","quote":"These non-clinical studies show that dasatinib can overcome imatinib resistance resulting from BCR-ABL overexpression, BCR-ABL kinase domain mutations, activation of alternate signalling pathways involving the SRC family kinases (LYN, HCK), and multidrug resistance gene overexpression.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/dasatinib-accord-healthcare-epar-product-information_en.pdf"},"copies":[]},{"key":"ceritinib__zykadia","inn":"ceritinib","brand":"Zykadia","company":"Novartis Europharm Limited","ema_product_number":"EMEA/H/C/003819","atc_code":"L01XE","authorised":"2015-05-06","pi_updated":"2026-01-29","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zykadia","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/zykadia-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/zykadia-epar-product-information_de.pdf","indication_text":"Zykadia as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).\nZykadia as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.","extracted":true,"target":{"targets":["ALK"],"modality":"small molecule","label":"ALK inhibitor","mechanism":"Ceritinib selectively inhibits autophosphorylation of ALK and downstream signalling, blocking proliferation of ALK-dependent cancer cells.","quote":"Ceritinib is an orally highly selective and potent ALK inhibitor.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/zykadia-epar-product-information_en.pdf"},"copies":[]},{"key":"tafasitamab__minjuvi","inn":"tafasitamab","brand":"Minjuvi","company":"Incyte Biosciences Distribution B.V.","ema_product_number":"EMEA/H/C/005436","atc_code":"L01FX12","authorised":"2021-08-26","pi_updated":"2026-01-27","conditional":true,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/minjuvi","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/minjuvi-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/minjuvi-epar-product-information_de.pdf","indication_text":"MINJUVI is indicated in combination with lenalidomide followed by MINJUVI monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).\nMINJUVI is indicated in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy.","extracted":true,"target":{"targets":["CD19"],"modality":"monoclonal antibody","label":"CD19-directed monoclonal antibody","mechanism":"Binds CD19 on B lymphocytes to mediate B-cell lysis through immune effector cell engagement (enhanced ADCC and ADCP) and direct induction of apoptosis.","quote":"Tafasitamab is an Fc-enhanced monoclonal antibody that targets the CD19 antigen expressed on the surface of pre-B and mature B lymphocytes.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/minjuvi-epar-product-information_en.pdf"},"copies":[]},{"key":"vismodegib__erivedge","inn":"vismodegib","brand":"Erivedge","company":"Roche Registration GmbH","ema_product_number":"EMEA/H/C/002602","atc_code":"L01XX43","authorised":"2013-07-12","pi_updated":"2025-11-05","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/erivedge","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/erivedge-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/erivedge-epar-product-information_de.pdf","indication_text":"Erivedge is indicated for the treatment of adult patients with: symptomatic metastatic basal cell carcinoma locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy (see section 5.1).","extracted":true,"target":{"targets":["SMO"],"modality":"small molecule","label":"Hedgehog pathway inhibitor","mechanism":"Vismodegib binds to and inhibits the Smoothened transmembrane protein, blocking Hedgehog pathway signal transduction.","quote":"Vismodegib binds to and inhibits the SMO protein thereby blocking Hedgehog signal transduction.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/erivedge-epar-product-information_en.pdf"},"copies":[]},{"key":"cemiplimab__libtayo","inn":"cemiplimab","brand":"Libtayo","company":"Regeneron Ireland Designated Activity Company (DAC)","ema_product_number":"EMEA/H/C/004844","atc_code":"L01XC33","authorised":"2019-06-28","pi_updated":"2025-12-10","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/libtayo","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/libtayo-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/libtayo-epar-product-information_de.pdf","indication_text":"Cutaneous Squamous Cell Carcinoma\nLIBTAYO as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation.\nLIBTAYO as monotherapy is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation (see section 5.1 for selection criteria).\nBasal Cell Carcinoma\nLIBTAYO as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI).\nNon-Small Cell Lung Cancer\nLIBTAYO as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ≥ 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have:\n• locally advanced NSCLC who are not candidates for definitive chemoradiation, or\n• metastatic NSCLC.\nLIBTAYO in combination with platinum-based chemotherapy is indicated for the first‐line treatment of adult patients with NSCLC expressing PD-L1 (in ≥ 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have:\n• locally advanced NSCLC who are not candidates for definitive chemoradiation, or\n• metastatic NSCLC.\nCervical Cancer\nLIBTAYO as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.","extracted":true,"target":{"targets":["PD-1"],"modality":"monoclonal antibody","label":"PD-1 inhibitor (antibody)","mechanism":"Binds to the PD-1 receptor and blocks interaction with PD-L1 and PD-L2, potentiating T-cell anti-tumour responses.","quote":"Cemiplimab potentiates T cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/libtayo-epar-product-information_en.pdf"},"copies":[]},{"key":"sonidegib__odomzo","inn":"sonidegib","brand":"Odomzo","company":"Sun Pharmaceutical Industries Europe B.V.","ema_product_number":"EMEA/H/C/002839","atc_code":"L01XJ02","authorised":"2015-08-14","pi_updated":"2025-11-17","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/odomzo","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/odomzo-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/odomzo-epar-product-information_de.pdf","indication_text":"Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.","extracted":true,"target":{"targets":["SMO"],"modality":"small molecule","label":"Smoothened inhibitor","mechanism":"Sonidegib binds to Smoothened, inhibiting Hedgehog signalling and blocking downstream signal transduction involved in proliferation, differentiation, and survival.","quote":"Sonidegib binding to Smo will inhibit Hh signalling and consequently block signal transduction.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/odomzo-epar-product-information_en.pdf"},"copies":[]},{"key":"abiraterone-acetate__abiraterone-krka","inn":"abiraterone acetate","brand":"Abiraterone Krka","company":"Krka, d.d., Novo mesto","ema_product_number":"EMEA/H/C/005649","atc_code":"L02BX03","authorised":"2021-06-24","pi_updated":"2026-01-16","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":true,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/abiraterone-krka","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/abiraterone-krka-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/abiraterone-krka-epar-product-information_de.pdf","indication_text":"Abiraterone Krka is indicated with prednisone or prednisolone for:\n- the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1)\n- the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1)\n- the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.","extracted":true,"target":{"targets":["CYP17A1"],"modality":"small molecule","label":"CYP17 inhibitor (androgen biosynthesis inhibitor)","mechanism":"Abiraterone selectively inhibits CYP17 (17α-hydroxylase/C17,20-lyase), blocking androgen biosynthesis in testicular, adrenal and prostatic tumour tissue and lowering serum testosterone.","quote":"Specifically, abiraterone selectively inhibits the enzyme 17α-hydroxylase/C17,20-lyase (CYP17).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/abiraterone-krka-epar-product-information_en.pdf"},"copies":[{"brand":"Abiraterone Mylan","company":"Mylan Pharmaceuticals Limited","kind":"generic","authorised":"2021-08-20","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/abiraterone-mylan"}]},{"key":"elranatamab__elrexfio","inn":"elranatamab","brand":"Elrexfio","company":"Pfizer Europe MA EEIG","ema_product_number":"EMEA/H/C/005908","atc_code":"","authorised":"2023-12-07","pi_updated":"2026-01-16","conditional":true,"exceptional":false,"orphan":false,"prime":true,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/elrexfio","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/elrexfio-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/elrexfio-epar-product-information_de.pdf","indication_text":"ELREXFIO is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.","extracted":true,"target":{"targets":["BCMA","CD3"],"modality":"bispecific antibody","label":"BCMA × CD3 bispecific antibody","mechanism":"Binds BCMA on myeloma cells and CD3 on T cells, activating T cells, releasing proinflammatory cytokines, and lysing multiple myeloma cells.","quote":"Elranatamab is a bi-specific T-cell engaging antibody that binds CD3-epsilon on T cells and B-cell maturation antigen (BCMA) on plasma cells, plasmablasts, and multiple myeloma cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/elrexfio-epar-product-information_en.pdf"},"copies":[]},{"key":"gilteritinib__xospata","inn":"gilteritinib","brand":"Xospata","company":"Astellas Pharma Europe B.V.","ema_product_number":"EMEA/H/C/004752","atc_code":"L01EX13","authorised":"2019-10-24","pi_updated":"2024-07-09","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/xospata","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/xospata-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/xospata-epar-product-information_de.pdf","indication_text":"Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation (see sections 4.2 and 5.1).","extracted":true,"target":{"targets":["FLT3","AXL"],"modality":"small molecule","label":"FLT3 and AXL inhibitor","mechanism":"Gilteritinib inhibits FLT3 and AXL, blocking FLT3 receptor signalling and cell proliferation, and inducing apoptosis in leukemic cells expressing FLT3-ITD.","quote":"Gilteritinib fumarate is a FLT3 and AXL inhibitor.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/xospata-epar-product-information_en.pdf"},"copies":[]},{"key":"ramucirumab__cyramza","inn":"ramucirumab","brand":"Cyramza","company":"Eli Lilly Nederland B.V.","ema_product_number":"EMEA/H/C/002829","atc_code":"L01FX06","authorised":"2014-12-19","pi_updated":"2026-01-16","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/cyramza","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/cyramza-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/cyramza-epar-product-information_de.pdf","indication_text":"Gastric cancer\nCyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy (see section 5.1).\nCyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate (see section 5.1).\nColorectal cancer\nCyramza, in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine.\nNon-small cell lung cancer\nCyramza in combination with erlotinib is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer with activating epidermal growth factor receptor (EGFR) mutations (see section 5.1).\nCyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy.\nHepatocellular carcinoma\nCyramza monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein (AFP) of ≥ 400 ng/ml and who have been previously treated with sorafenib.","extracted":true,"target":{"targets":["VEGFR2"],"modality":"monoclonal antibody","label":"VEGFR2 inhibitor antibody","mechanism":"Ramucirumab binds VEGF Receptor 2 to block VEGF ligand binding and activation, inhibiting endothelial cell proliferation and migration.","quote":"Ramucirumab is a human receptor-targeted antibody that specifically binds VEGF Receptor 2 and blocks binding of VEGF-A, VEGF-C, and VEGF-D.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/cyramza-epar-product-information_en.pdf"},"copies":[]},{"key":"abiraterone__zytiga","inn":"abiraterone","brand":"Zytiga","company":"Janssen-Cilag International","ema_product_number":"EMEA/H/C/002321","atc_code":"L02BX03","authorised":"2011-09-05","pi_updated":"2024-10-18","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zytiga","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/zytiga-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/zytiga-epar-product-information_de.pdf","indication_text":"ZYTIGA is indicated with prednisone or prednisolone for:\n the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1)  the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1)  the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.","extracted":true,"target":{"targets":["CYP17"],"modality":"small molecule","label":"CYP17 inhibitor (androgen biosynthesis inhibitor)","mechanism":"Abiraterone selectively inhibits CYP17 (17α-hydroxylase/C17,20-lyase), blocking androgen synthesis in testes, adrenals and prostate tumour; with LHRH analogues it drops testosterone to undetectable levels.","quote":"Specifically, abiraterone selectively inhibits the enzyme 17α-hydroxylase/C17,20-lyase (CYP17).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/zytiga-epar-product-information_en.pdf"},"copies":[{"brand":"Abiraterone Accord","company":"Accord Healthcare S.L.U.","kind":"generic","authorised":"2021-04-26","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/abiraterone-accord"}]},{"key":"midostaurin__rydapt","inn":"midostaurin","brand":"Rydapt","company":"Novartis Europharm Ltd","ema_product_number":"EMEA/H/C/004095","atc_code":"L01XE","authorised":"2017-09-18","pi_updated":"2026-01-14","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/rydapt","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/rydapt-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/rydapt-epar-product-information_de.pdf","indication_text":"Rydapt is indicated:\n• in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive (see section 4.2);\n• as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL).","extracted":true,"target":{"targets":["FLT3","KIT","PDGFR","VEGFR2","PKC"],"modality":"small molecule","label":"Multikinase inhibitor (FLT3, KIT)","mechanism":"Midostaurin binds the catalytic domain of receptor tyrosine kinases including FLT3 and KIT, inhibiting downstream signalling to cause cell cycle arrest and apoptosis.","quote":"Midostaurin inhibits multiple receptor tyrosine kinases, including FLT3 and KIT kinase.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/rydapt-epar-product-information_en.pdf"},"copies":[]},{"key":"bosutinib__bosulif","inn":"bosutinib","brand":"Bosulif","company":"Pfizer Europe MA EEIG","ema_product_number":"EMEA/H/C/002373","atc_code":"L01EA04","authorised":"2013-03-27","pi_updated":"2026-01-12","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/bosulif","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/bosulif-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/bosulif-epar-product-information_de.pdf","indication_text":"Bosulif is indicated for the treatment of:\n Adult and paediatric patients aged 6 years and older with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).\n Adult and paediatric patients aged 6 years and older with CP Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.\n Adult patients with accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.","extracted":true,"target":{"targets":["BCR-ABL","SRC","LYN","HCK"],"modality":"small molecule","label":"BCR-ABL and Src family kinase inhibitor","mechanism":"Bosutinib binds the kinase domain of the abnormal BCR-ABL kinase and also inhibits Src family kinases (Src, Lyn, Hck), suppressing proliferation and survival of CML and Ph+ ALL cells.","quote":"Bosutinib inhibits the abnormal BCR-ABL kinase that promotes CML.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/bosulif-epar-product-information_en.pdf"},"copies":[]},{"key":"lapatinib__tyverb","inn":"lapatinib","brand":"Tyverb","company":"Novartis Europharm Limited","ema_product_number":"EMEA/H/C/000795","atc_code":"L01EH01","authorised":"2008-06-10","pi_updated":"2026-01-06","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tyverb","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/tyverb-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/tyverb-epar-product-information_de.pdf","indication_text":"Tyverb is indicated for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2);\n• in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting (see section 5.1).\n• in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy (see section 5.1).\n• in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study were not previously treated with trastuzumab or an aromatase inhibitor (see sections 4.4. and 5.1). No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population.","extracted":true,"target":{"targets":["EGFR","HER2"],"modality":"small molecule","label":"Dual EGFR and HER2 kinase inhibitor","mechanism":"Lapatinib inhibits the intracellular tyrosine kinase domains of both EGFR and HER2 receptors, thereby inhibiting ErbB-driven tumour cell growth.","quote":"Lapatinib, a 4-anilinoquinazoline, is an inhibitor of the intracellular tyrosine kinase domains of both EGFR (ErbB1) and of HER2 (ErbB2) receptors (estimated Kiapp values of 3nM and 13nM, respectively) with a slow off-rate from these receptors (half-life greater than or equal to 300 minutes).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/tyverb-epar-product-information_en.pdf"},"copies":[]},{"key":"talimogene-laherparepvec__imlygic","inn":"talimogene laherparepvec","brand":"Imlygic","company":"Amgen Europe B.V.","ema_product_number":"EMEA/H/C/002771","atc_code":"L01XX51","authorised":"2015-12-16","pi_updated":"2026-01-06","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":true,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/imlygic","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/imlygic-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/imlygic-epar-product-information_de.pdf","indication_text":"Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease (see sections 4.4 and 5.1).","extracted":true,"target":{"targets":[],"modality":"oncolytic virus","label":"Oncolytic viral immunotherapy","mechanism":"Selectively replicates within tumour cells to cause lysis and release of tumour antigens, while expressing human GM-CSF to promote a systemic anti-tumour immune response.","quote":"Talimogene laherparepvec has been modified to replicate within tumours and to produce the immune stimulatory protein human GM-CSF.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/imlygic-epar-product-information_en.pdf"},"copies":[]},{"key":"nilotinib__tasigna","inn":"nilotinib","brand":"Tasigna","company":"Novartis Europharm Limited","ema_product_number":"EMEA/H/C/000798","atc_code":"L01EA03","authorised":"2007-11-19","pi_updated":"2025-12-17","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tasigna","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/tasigna-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/tasigna-epar-product-information_de.pdf","indication_text":"Tasigna is indicated for the treatment of:\n- adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase,\n- adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available,\n- paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.","extracted":true,"target":{"targets":["BCR-ABL"],"modality":"small molecule","label":"BCR-ABL tyrosine kinase inhibitor","mechanism":"Nilotinib binds the ATP-binding site of the BCR-ABL oncoprotein, inhibiting its kinase activity to block proliferation and induce apoptosis in Philadelphia-chromosome positive leukaemia cells.","quote":"Nilotinib is a potent inhibitor of the ABL tyrosine kinase activity of the BCR-ABL oncoprotein both in cell lines and in primary Philadelphia-chromosome positive leukaemia cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/tasigna-epar-product-information_en.pdf"},"copies":[{"brand":"Nilotinib Accord","company":"Accord Healthcare S.L.U.","kind":"generic","authorised":"2024-08-22","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/nilotinib-accord"}]},{"key":"tebentafusp__kimmtrak","inn":"tebentafusp","brand":"Kimmtrak","company":"Immunocore Ireland Limited","ema_product_number":"EMEA/H/C/004929","atc_code":"L01XX75","authorised":"2022-04-01","pi_updated":"2025-12-09","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/kimmtrak","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/kimmtrak-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/kimmtrak-epar-product-information_de.pdf","indication_text":"KIMMTRAK is indicated as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.","extracted":true,"target":{"targets":["gp100 peptide/HLA-A*02:01","CD3"],"modality":"protein or peptide","label":"gp100/HLA-A*02:01 × CD3 bispecific fusion protein","mechanism":"Its TCR arm binds gp100 peptide presented by HLA-A*02:01 on uveal melanoma cells and its anti-CD3 arm binds T cells, redirecting and activating polyclonal T cells to lyse tumour cells.","quote":"The TCR end binds with high affinity to a gp100 peptide presented by human leukocyte antigen – A*02:01 (HLA-A*02:01) on the cell surface of uveal melanoma tumour cells, and the effector domain binds to the CD3 receptor on the polyclonal T cell.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/kimmtrak-epar-product-information_en.pdf"},"copies":[]},{"key":"idecabtagene-vicleucel__abecma","inn":"idecabtagene vicleucel","brand":"Abecma","company":"Bristol-Myers Squibb Pharma EEIG","ema_product_number":"EMEA/H/C/004662","atc_code":"L01","authorised":"2021-08-18","pi_updated":"2025-12-09","conditional":false,"exceptional":false,"orphan":true,"prime":true,"advanced_therapy":true,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/abecma","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/abecma-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/abecma-epar-product-information_de.pdf","indication_text":"Abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.","extracted":true,"target":{"targets":["BCMA"],"modality":"cell therapy","label":"BCMA-directed CAR T-cell therapy","mechanism":"Binds BCMA on plasma cells to trigger CAR T-cell activation, proliferation, cytokine secretion, and cytolytic killing of BCMA-expressing cells.","quote":"Abecma is a chimeric antigen receptor (CAR)-positive T cell therapy targeting B-cell maturation antigen (BCMA), which is expressed on the surface of normal and malignant plasma cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/abecma-epar-product-information_en.pdf"},"copies":[]},{"key":"talquetamab__talvey","inn":"talquetamab","brand":"Talvey","company":"Janssen-Cilag International N.V.","ema_product_number":"EMEA/H/C/005864","atc_code":"L01FX29","authorised":"2023-08-21","pi_updated":"2025-11-28","conditional":true,"exceptional":false,"orphan":true,"prime":true,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/talvey","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/talvey-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/talvey-epar-product-information_de.pdf","indication_text":"TALVEY is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.","extracted":true,"target":{"targets":["GPRC5D","CD3"],"modality":"bispecific antibody","label":"GPRC5D × CD3 bispecific antibody","mechanism":"Binds GPRC5D and CD3 to recruit T cells to GPRC5D-expressing cells, triggering T-cell activation and perforin- and granzyme-mediated lysis.","quote":"Talquetamab is a immunoglobulin G4 proline, alanine, alanine (IgG4 PAA) bispecific antibody directed against GPRC5D and the CD3 receptor on T Cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/talvey-epar-product-information_en.pdf"},"copies":[]},{"key":"tucatinib__tukysa","inn":"tucatinib","brand":"Tukysa","company":"Pfizer Europe MA EEIG","ema_product_number":"EMEA/H/C/005263","atc_code":"L01EH03","authorised":"2021-02-11","pi_updated":"2025-11-25","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tukysa","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/tukysa-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/tukysa-epar-product-information_de.pdf","indication_text":"TUKYSA is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens.","extracted":true,"target":{"targets":["HER2"],"modality":"small molecule","label":"HER2 tyrosine kinase inhibitor","mechanism":"Tucatinib selectively inhibits HER2 tyrosine kinase, blocking downstream signaling and cell proliferation while inducing death in HER2-driven tumor cells.","quote":"Tucatinib is a reversible, potent and selective tyrosine kinase inhibitor of HER2.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/tukysa-epar-product-information_en.pdf"},"copies":[]},{"key":"ruxolitinib__jakavi","inn":"ruxolitinib","brand":"Jakavi","company":"Novartis Europharm Limited","ema_product_number":"EMEA/H/C/002464","atc_code":"L01EJ01","authorised":"2012-08-23","pi_updated":"2025-11-10","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/jakavi","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/jakavi-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/jakavi-epar-product-information_de.pdf","indication_text":"Myelofibrosis (MF)\nJakavi is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.\nPolycythaemia vera (PV)\nJakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.\nGraft versus host disease (GvHD)\nAcute GvHD\nJakavi is indicated for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).\nChronic GvHD\nJakavi is indicated for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).","extracted":true,"target":{"targets":["JAK1","JAK2"],"modality":"small molecule","label":"JAK1 and JAK2 inhibitor","mechanism":"Ruxolitinib selectively inhibits JAK1 and JAK2, blocking downstream JAK-STAT signaling and the proliferation of cytokine-dependent malignant cells.","quote":"Ruxolitinib is a selective inhibitor of the Janus Associated Kinases (JAKs) JAK1 and JAK2 (IC50 values of 3.3 nM and 2.8 nM for JAK1 and JAK2 enzymes, respectively).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/jakavi-epar-product-information_en.pdf"},"copies":[]},{"key":"binimetinib__mektovi","inn":"binimetinib","brand":"Mektovi","company":"Pierre Fabre Medicament","ema_product_number":"EMEA/H/C/004579","atc_code":"L01EE03","authorised":"2018-09-20","pi_updated":"2025-11-05","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/mektovi","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/mektovi-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/mektovi-epar-product-information_de.pdf","indication_text":"Melanoma\nBinimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.\nNon-small cell lung cancer (NSCLC)\nBinimetinib in combination with encorafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.","extracted":true,"target":{"targets":["MEK1/2"],"modality":"small molecule","label":"MEK1/2 inhibitor","mechanism":"Binimetinib is an ATP-uncompetitive, reversible inhibitor of MEK1 and MEK2 kinase activity that blocks MEK activation by BRAF, suppressing ERK/MAPK pathway signalling and proliferation.","quote":"Binimetinib is an ATP-uncompetitive, reversible inhibitor of the kinase activity of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/mektovi-epar-product-information_en.pdf"},"copies":[]},{"key":"futibatinib__lytgobi","inn":"futibatinib","brand":"Lytgobi","company":"Taiho Pharma Netherlands B.V.","ema_product_number":"EMEA/H/C/005627","atc_code":"L01EN04","authorised":"2023-07-04","pi_updated":"2025-10-29","conditional":true,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lytgobi","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/lytgobi-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/lytgobi-epar-product-information_de.pdf","indication_text":"Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.","extracted":true,"target":{"targets":["FGFR1","FGFR2","FGFR3","FGFR4"],"modality":"small molecule","label":"Irreversible FGFR 1-4 inhibitor","mechanism":"Futibatinib is a kinase inhibitor that irreversibly inhibits FGFR 1, 2, 3, and 4 by covalent binding, blocking constitutive FGFR signalling.","quote":"Futibatinib is a tyrosine kinase inhibitor that irreversibly inhibits FGFR 1, 2, 3, and 4 by covalent binding.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/lytgobi-epar-product-information_en.pdf"},"copies":[]},{"key":"pertuzumab-trastuzumab__phesgo","inn":"pertuzumab;trastuzumab","brand":"Phesgo","company":"Roche Registration GmbH","ema_product_number":"EMEA/H/C/005386","atc_code":"L01XY","authorised":"2020-12-21","pi_updated":"2025-10-28","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/phesgo","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/phesgo-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/phesgo-epar-product-information_de.pdf","indication_text":"Early breast cancer (EBC)\nPhesgo is indicated for use in combination with chemotherapy in:\n• the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence (see section 5.1)\n• the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1) Metastatic breast cancer (MBC) Phesgo is indicated for use in combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.","extracted":true,"target":{"targets":["HER2"],"modality":"monoclonal antibody","label":"Dual HER2-directed monoclonal antibody combination","mechanism":"Pertuzumab and trastuzumab bind distinct subdomains of HER2, blocking HER2 heterodimerization and signalling pathways to halt cell proliferation and mediate ADCC.","quote":"Pertuzumab and trastuzumab are recombinant humanised IgG1 monoclonal antibodies which target the human epidermal growth factor receptor 2 (HER2).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/phesgo-epar-product-information_en.pdf"},"copies":[]},{"key":"pazopanib__votrient","inn":"pazopanib","brand":"Votrient","company":"Novartis Europharm Limited","ema_product_number":"EMEA/H/C/001141","atc_code":"L01XE11","authorised":"2010-06-14","pi_updated":"2025-10-28","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/votrient","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/votrient-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/votrient-epar-product-information_de.pdf","indication_text":"Renal cell carcinoma (RCC)\nVotrient is indicated in adults for the first-line treatment of advanced renal cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease.\nSoft-tissue sarcoma (STS)\nVotrient is indicated for the treatment of adult patients with selective subtypes of advanced soft-tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy.\nEfficacy and safety has only been established in certain STS histological tumour subtypes (see section 5.1).","extracted":true,"target":{"targets":["VEGFR1","VEGFR2","VEGFR3","PDGFRA","PDGFRB","KIT"],"modality":"small molecule","label":"Multikinase inhibitor (VEGFR, PDGFR, KIT)","mechanism":"Pazopanib inhibits VEGFR-1/-2/-3, PDGFR-α/-β, and c-KIT receptor tyrosine kinases, blocking ligand-induced phosphorylation and suppressing tumor angiogenesis and growth.","quote":"Pazopanib is an orally administered, potent multi-target tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3, platelet-derived growth factor (PDGFR) -α and –β, and stem cell factor receptor (c-KIT), with IC50 values of 10, 30, 47, 71, 84 and 74 nM, respectively.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/votrient-epar-product-information_en.pdf"},"copies":[]},{"key":"tagraxofusp__elzonris","inn":"tagraxofusp","brand":"Elzonris","company":"Stemline Therapeutics B.V.","ema_product_number":"EMEA/H/C/005031","atc_code":"L01XX67","authorised":"2021-01-07","pi_updated":"2025-10-27","conditional":false,"exceptional":true,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/elzonris","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/elzonris-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/elzonris-epar-product-information_de.pdf","indication_text":"ELZONRIS is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) (see section 5.1).","extracted":true,"target":{"targets":["CD123"],"modality":"protein or peptide","label":"CD123-directed cytotoxin","mechanism":"It targets CD123-expressing cells and irreversibly inhibits protein synthesis by inactivating elongation factor 2, causing apoptosis.","quote":"Tagraxofusp is a CD123-directed cytotoxin composed of recombinant human interleukin-3 (IL-3) and truncated diphtheria toxin (DT) fusion protein that targets CD123-expressing cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/elzonris-epar-product-information_en.pdf"},"copies":[]},{"key":"panobinostat__farydak","inn":"panobinostat","brand":"Farydak","company":"pharmaand GmbH","ema_product_number":"EMEA/H/C/003725","atc_code":"L01XH03","authorised":"2015-08-28","pi_updated":"2025-10-01","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/farydak","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/farydak-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/farydak-epar-product-information_de.pdf","indication_text":"Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.","extracted":true,"target":{"targets":["HDAC"],"modality":"small molecule","label":"Histone deacetylase (HDAC) inhibitor","mechanism":"Inhibits HDAC enzymatic activity, increasing acetylation of histones and other proteins, relaxing chromatin and inducing cell cycle arrest and/or apoptosis of transformed cells.","quote":"Farydak is a histone deacetylase (HDAC) inhibitor that inhibits the enzymatic activity of HDACs at nanomolar concentrations.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/farydak-epar-product-information_en.pdf"},"copies":[]},{"key":"elotuzumab__empliciti","inn":"elotuzumab","brand":"Empliciti","company":"Bristol-Myers Squibb Pharma EEIG","ema_product_number":"EMEA/H/C/003967","atc_code":"L01FX08","authorised":"2016-05-11","pi_updated":"2025-09-29","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/empliciti","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/empliciti-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/empliciti-epar-product-information_de.pdf","indication_text":"Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy (see sections 4.2 and 5.1).\nEmpliciti is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy (see sections 4.2 and 5.1).","extracted":true,"target":{"targets":["SLAMF7"],"modality":"monoclonal antibody","label":"SLAMF7-directed monoclonal antibody","mechanism":"It targets SLAMF7, directly activating natural killer cells and facilitating myeloma cell killing through antibody-dependent cellular cytotoxicity and phagocytosis.","quote":"Elotuzumab is an immunostimulatory humanised, IgG1 monoclonal antibody that specifically targets the signaling lymphocyte activation molecule family member 7 (SLAMF7) protein.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/empliciti-epar-product-information_en.pdf"},"copies":[]},{"key":"thalidomide__thalidomide-lipomed","inn":"thalidomide","brand":"Thalidomide Lipomed","company":"Lipomed GmbH","ema_product_number":"EMEA/H/C/005715","atc_code":"L04AX02","authorised":"2022-09-19","pi_updated":"2024-05-14","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/thalidomide-lipomed","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/thalidomide-lipomed-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/thalidomide-lipomed-epar-product-information_de.pdf","indication_text":"Thalidomide Lipomed in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy.\nThalidomide Lipomed is prescribed and dispensed in accordance with the Thalidomide Lipomed Pregnancy Prevention Programme (see section 4.4).","extracted":true,"target":{"targets":["TNF-α"],"modality":"small molecule","label":"Immunomodulatory agent","mechanism":"Thalidomide may act by suppressing excessive TNF-α production, down-modulating cell surface adhesion molecules involved in leukocyte migration, and through anti-angiogenic activity.","quote":"Data from in vitro studies and clinical trials suggest that the immunomodulatory, anti-inflammatory and anti-neoplastic effects of thalidomide may be related to suppression of excessive tumour necrosis factor-alpha (TNF-α) production, down-modulation of selected cell surface adhesion molecules involved in leukocyte migration and anti-angiogenic activity.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/thalidomide-lipomed-epar-product-information_en.pdf"},"copies":[]},{"key":"thalidomide__thalidomide-bms-previously-thalidomide-celgene-","inn":"thalidomide","brand":"Thalidomide BMS (previously Thalidomide Celgene)","company":"Bristol-Myers Squibb Pharma EEIG","ema_product_number":"EMEA/H/C/000823","atc_code":"L04AX02","authorised":"2008-04-16","pi_updated":"2025-01-22","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/thalidomide-bms","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/thalidomide-bms-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/thalidomide-bms-epar-product-information_de.pdf","indication_text":"Thalidomide BMS in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy.\nThalidomide BMS is prescribed and dispensed according to the Thalidomide BMS Pregnancy Prevention Programme (see section 4.4).","extracted":true,"target":{"targets":["TNF-α"],"modality":"small molecule","label":"Immunomodulatory agent","mechanism":"Thalidomide's immunomodulatory and anti-neoplastic effects may relate to suppression of excess TNF-α production, down-modulation of leukocyte adhesion molecules and anti-angiogenic activity.","quote":"Data from in vitro studies and clinical trials suggest that the immunomodulatory, anti-inflammatory and anti-neoplastic effects of thalidomide may be related to suppression of excessive tumour necrosis factor-alpha (TNF-α) production, down-modulation of selected cell surface adhesion molecules involved in leukocyte migration and anti-angiogenic activity.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/thalidomide-bms-epar-product-information_en.pdf"},"copies":[]},{"key":"axitinib__inlyta","inn":"axitinib","brand":"Inlyta","company":"Pfizer Europe MA EEIG","ema_product_number":"EMEA/H/C/002406","atc_code":"L01EK01","authorised":"2012-09-03","pi_updated":"2025-01-22","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/inlyta","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/inlyta-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/inlyta-epar-product-information_de.pdf","indication_text":"Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.","extracted":true,"target":{"targets":["VEGFR1","VEGFR2","VEGFR3"],"modality":"small molecule","label":"VEGFR tyrosine kinase inhibitor","mechanism":"Axitinib selectively inhibits VEGFR-1, VEGFR-2, and VEGFR-3 tyrosine kinases, blocking VEGF-mediated endothelial cell proliferation and survival to inhibit pathologic angiogenesis and tumor growth.","quote":"Axitinib is a potent and selective tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2 and VEGFR-3.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/inlyta-epar-product-information_en.pdf"},"copies":[{"brand":"Axitinib Accord","company":"Accord Healthcare S.L.U.","kind":"generic","authorised":"2024-09-19","epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/axitinib-accord"}]},{"key":"talazoparib__talzenna","inn":"talazoparib","brand":"Talzenna","company":"Pfizer Europe MA EEIG","ema_product_number":"EMEA/H/C/004674","atc_code":"L01XK04","authorised":"2019-06-20","pi_updated":"2025-07-18","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/talzenna","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/talzenna-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/talzenna-epar-product-information_de.pdf","indication_text":"Breast cancer\nTalzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments (see section 5.1).\nPatients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.\nProstate cancer\nTalzenna is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.","extracted":true,"target":{"targets":["PARP1","PARP2"],"modality":"small molecule","label":"PARP inhibitor","mechanism":"Inhibits PARP1 and PARP2 catalytic activity and traps PARP on DNA lesions, preventing DNA repair and inducing apoptosis.","quote":"Talazoparib is an inhibitor of PARP enzymes, PARP1 (IC50=0.7 nM), and PARP2 (IC50=0.3 nM).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/talzenna-epar-product-information_en.pdf"},"copies":[]},{"key":"darolutamide__nubeqa","inn":"darolutamide","brand":"Nubeqa","company":"Bayer AG","ema_product_number":"EMEA/H/C/004790","atc_code":"L02BB","authorised":"2020-03-27","pi_updated":"2025-08-21","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/nubeqa","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/nubeqa-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/nubeqa-epar-product-information_de.pdf","indication_text":"NUBEQA is indicated for the treatment of adult men with\n- non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1).\n- metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1).\n- metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (see section 5.1).","extracted":true,"target":{"targets":["androgen receptor"],"modality":"small molecule","label":"Androgen receptor inhibitor","mechanism":"Binds the androgen receptor ligand-binding domain, competitively inhibiting androgen binding, AR nuclear translocation and AR-mediated transcription, decreasing prostate tumour cell proliferation.","quote":"Darolutamide is an androgen receptor (AR) inhibitor with a flexible polar-substituted pyrazole structure that binds with high affinity directly to the receptor ligand binding domain.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/nubeqa-epar-product-information_en.pdf"},"copies":[]},{"key":"capmatinib__tabrecta","inn":"capmatinib","brand":"Tabrecta","company":"Novartis Europharm Limited","ema_product_number":"EMEA/H/C/004845","atc_code":"L01EX17","authorised":"2022-06-20","pi_updated":"2025-08-27","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tabrecta","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/tabrecta-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/tabrecta-epar-product-information_de.pdf","indication_text":"Tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.","extracted":true,"target":{"targets":["MET"],"modality":"small molecule","label":"MET tyrosine kinase inhibitor","mechanism":"Capmatinib inhibits MET phosphorylation and downstream signalling, blocking the proliferation and survival of MET-dependent cancer cells.","quote":"Capmatinib is an inhibitor of the MET receptor tyrosine kinase.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/tabrecta-epar-product-information_en.pdf"},"copies":[]},{"key":"obecabtagene-autoleucel__aucatzyl","inn":"obecabtagene autoleucel","brand":"Aucatzyl","company":"Autolus GmbH","ema_product_number":"EMEA/H/C/005907","atc_code":"L01XL","authorised":"2025-07-17","pi_updated":"2025-08-19","conditional":true,"exceptional":false,"orphan":false,"prime":true,"advanced_therapy":true,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/aucatzyl","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/aucatzyl-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/aucatzyl-epar-product-information_de.pdf","indication_text":"Aucatzyl is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B cell precursor acute lymphoblastic leukaemia (B ALL).","extracted":true,"target":{"targets":["CD19"],"modality":"cell therapy","label":"CD19-directed CAR T-cell therapy","mechanism":"Autologous CAR T cells bind CD19 on target cells, leading to CAR T-cell activation, proliferation, and anti-tumour killing of CD19-expressing cells.","quote":"Obecabtagene autoleucel is an autologous immunotherapy consisting of the patient’s own T cells engineered to express a CAR that recognises CD19 on-target cells via the murine CAT13.1E10 hybridoma (CAT) binding domain.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/aucatzyl-epar-product-information_en.pdf"},"copies":[]},{"key":"bexarotene__targretin","inn":"bexarotene","brand":"Targretin","company":"H.A.C. Pharma","ema_product_number":"EMEA/H/C/000326","atc_code":"L01XF03","authorised":"2001-03-29","pi_updated":"2025-08-12","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/targretin","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/targretin-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/targretin-epar-product-information_de.pdf","indication_text":"Targretin is indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) in adult patients refractory to at least one systemic treatment.","extracted":true,"target":{"targets":["RXRα","RXRβ","RXRγ"],"modality":"small molecule","label":"Retinoid X receptor (RXR) agonist (rexinoid)","mechanism":"Bexarotene selectively binds and activates the three retinoid X receptors, which act as transcription factors regulating cell differentiation, proliferation and apoptosis. Its exact action in CTCL is unknown.","quote":"Bexarotene is a synthetic compound that exerts its biological action through selective binding and activation of the three RXRs: , , and .","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/targretin-epar-product-information_en.pdf"},"copies":[]},{"key":"linvoseltamab__lynozyfic","inn":"linvoseltamab","brand":"Lynozyfic","company":"Regeneron Ireland Designated Activity Company (DAC)","ema_product_number":"EMEA/H/C/006370","atc_code":"L01FX","authorised":"2025-04-23","pi_updated":"2025-07-22","conditional":true,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lynozyfic","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/lynozyfic-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/lynozyfic-epar-product-information_de.pdf","indication_text":"LYNOZYFIC is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.","extracted":true,"target":{"targets":["BCMA","CD3"],"modality":"bispecific antibody","label":"BCMA × CD3 bispecific antibody","mechanism":"It binds CD3 on T cells and BCMA on malignant myeloma cells, triggering T-cell activation and redirected lysis of BCMA-expressing cells.","quote":"Linvoseltamab is a human IgG4-based bispecific antibody that binds to cluster of differentiation 3 (CD3), a T-cell antigen associated with the T-cell receptor complex, and B-cell maturation antigen (BCMA), which is expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B cells and plasma cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/lynozyfic-epar-product-information_en.pdf"},"copies":[]},{"key":"cobimetinib__cotellic","inn":"cobimetinib","brand":"Cotellic","company":"Roche Registration GmbH","ema_product_number":"EMEA/H/C/003960","atc_code":"L01XE38","authorised":"2015-11-20","pi_updated":"2025-06-24","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/cotellic","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/cotellic-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/cotellic-epar-product-information_de.pdf","indication_text":"Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).","extracted":true,"target":{"targets":["MEK1/2"],"modality":"small molecule","label":"MEK1/2 inhibitor","mechanism":"Cobimetinib is an allosteric inhibitor of MEK1 and MEK2 that blocks ERK phosphorylation, preventing MAPK pathway-driven cell proliferation.","quote":"Cobimetinib is a reversible, selective, allosteric, oral inhibitor that blocks the mitogen-activated protein kinase (MAPK) pathway by targeting the mitogen-activated extracellular signal-regulated kinase (MEK) 1 and MEK 2 which results in inhibition of phosphorylation of the extracellular signal- regulated kinase (ERK) 1 and ERK 2.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/cotellic-epar-product-information_en.pdf"},"copies":[]},{"key":"vemurafenib__zelboraf","inn":"vemurafenib","brand":"Zelboraf","company":"Roche Registration GmbH","ema_product_number":"EMEA/H/C/002409","atc_code":"L01EC01","authorised":"2012-02-17","pi_updated":"2025-06-19","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zelboraf","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/zelboraf-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/zelboraf-epar-product-information_de.pdf","indication_text":"Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma (see section 5.1).","extracted":true,"target":{"targets":["BRAF"],"modality":"small molecule","label":"BRAF inhibitor","mechanism":"Inhibits BRAF serine-threonine kinase with activating codon 600 mutations, suppressing ERK phosphorylation and cellular proliferation.","quote":"Vemurafenib is an inhibitor of BRAF serine-threonine kinase.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/zelboraf-epar-product-information_en.pdf"},"copies":[]},{"key":"neratinib__nerlynx","inn":"neratinib","brand":"Nerlynx","company":"Pierre Fabre Medicament","ema_product_number":"EMEA/H/C/004030","atc_code":"L01EH02","authorised":"2018-08-31","pi_updated":"2025-10-27","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/nerlynx","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/nerlynx-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/nerlynx-epar-product-information_de.pdf","indication_text":"Nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.","extracted":true,"target":{"targets":["HER2","EGFR","HER4"],"modality":"small molecule","label":"Irreversible pan-HER tyrosine kinase inhibitor","mechanism":"Covalently and irreversibly binds the ATP site of EGFR, HER2 and HER4, reducing receptor autophosphorylation and downstream MAPK/AKT signalling and inhibiting tumour cell proliferation.","quote":"Neratinib is an irreversible pan–erythroblastic leukaemia viral oncogene homolog (ERBB) tyrosine kinase inhibitor (TKI) that blocks mitogenic growth factor signal transduction through covalent, high affinity binding to the ATP binding site of 3 epidermal growth factor receptors (EGFRs): EGFR (encoded by ERBB1), HER2 (encoded by ERBB2), and HER4 (encoded by ERBB4) or their active heterodimers with HER3 (encoded by ERBB3).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/nerlynx-epar-product-information_en.pdf"},"copies":[]},{"key":"imetelstat__rytelo","inn":"imetelstat","brand":"Rytelo","company":"Geron Netherlands B.V.","ema_product_number":"EMEA/H/C/006105","atc_code":"L01XX80","authorised":"2025-03-07","pi_updated":"2025-05-15","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/rytelo","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/rytelo-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/rytelo-epar-product-information_de.pdf","indication_text":"Rytelo is indicated as monotherapy for the treatment of adult patients with transfusion-dependent anaemia due to very low, low or intermediate risk myelodysplastic syndromes (MDS) without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy (see section 5.1).","extracted":true,"target":{"targets":["telomerase RNA component (hTR)"],"modality":"other","label":"Oligonucleotide telomerase inhibitor","mechanism":"Oligonucleotide that binds the template region of telomerase's RNA component (hTR), blocking telomere binding; shortens telomeres and causes apoptosis of malignant stem and progenitor cells.","quote":"Imetelstat is an oligonucleotide telomerase inhibitor that binds to the template region of the RNA component of human telomerase (hTR), which prevents telomere binding.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/rytelo-epar-product-information_en.pdf"},"copies":[]},{"key":"panitumumab__vectibix","inn":"panitumumab","brand":"Vectibix","company":"Amgen Europe B.V.","ema_product_number":"EMEA/H/C/000741","atc_code":"L01XC08","authorised":"2007-12-03","pi_updated":"2025-05-07","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/vectibix","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/vectibix-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/vectibix-epar-product-information_de.pdf","indication_text":"Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC):\n• in first-line in combination with FOLFOX or FOLFIRI.\n• in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).\n• as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.","extracted":true,"target":{"targets":["EGFR"],"modality":"monoclonal antibody","label":"EGFR-directed monoclonal antibody","mechanism":"Panitumumab binds to the ligand-binding domain of EGFR, inhibiting ligand-induced receptor autophosphorylation and cell growth, while inducing receptor internalization and apoptosis.","quote":"Panitumumab is a recombinant, fully human IgG2 monoclonal antibody that binds with high affinity and specificity to the human EGFR.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/vectibix-epar-product-information_en.pdf"},"copies":[]},{"key":"glasdegib__daurismo","inn":"glasdegib","brand":"Daurismo","company":"Pfizer Europe MA EEIG","ema_product_number":"EMEA/H/C/004878","atc_code":"L01XX63","authorised":"2020-06-26","pi_updated":"2025-05-07","conditional":false,"exceptional":false,"orphan":true,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/daurismo","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/daurismo-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/daurismo-epar-product-information_de.pdf","indication_text":"Daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (AML) in adult patients who are not candidates for standard induction chemotherapy.","extracted":true,"target":{"targets":["SMO"],"modality":"small molecule","label":"Smoothened inhibitor","mechanism":"Binds to Smoothened (SMO) to inhibit Hedgehog signal transduction, reducing GLI transcription factor activity and downstream pathway signalling.","quote":"Glasdegib is an inhibitor of the Hedgehog (Hh) signal transduction pathway that binds to Smoothened (SMO), a transmembrane protein, leading to decreased Glioma-Associated Oncogene (GLI) transcription factor activity and downstream pathway signalling.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/daurismo-epar-product-information_en.pdf"},"copies":[]},{"key":"brigatinib__alunbrig","inn":"brigatinib","brand":"Alunbrig","company":"Takeda Pharma A/S","ema_product_number":"EMEA/H/C/004248","atc_code":"L01XE43","authorised":"2018-11-22","pi_updated":"2025-04-25","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/alunbrig","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/alunbrig-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/alunbrig-epar-product-information_de.pdf","indication_text":"Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.\nAlunbrig is indicated as monotherapy for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.","extracted":true,"target":{"targets":["ALK","ROS1","IGF-1R"],"modality":"small molecule","label":"ALK and ROS1 tyrosine kinase inhibitor","mechanism":"Tyrosine kinase inhibitor targeting ALK, ROS1, and IGF-1R that inhibits ALK autophosphorylation and downstream STAT3 signalling to suppress tumor cell growth.","quote":"Brigatinib is a tyrosine kinase inhibitor that targets ALK, c-ros oncogene 1 (ROS1), and insulin-like growth factor 1 receptor (IGF-1R).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/alunbrig-epar-product-information_en.pdf"},"copies":[]},{"key":"erlotinib__tarceva","inn":"erlotinib","brand":"Tarceva","company":"Cheplapharm Registration GmbH","ema_product_number":"EMEA/H/C/000618","atc_code":"L01EB02","authorised":"2005-09-19","pi_updated":"2025-03-05","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/tarceva","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/tarceva-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/tarceva-epar-product-information_de.pdf","indication_text":"Non-Small Cell Lung Cancer (NSCLC)\nTarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations.\nTarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy.\nTarceva is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable.\nWhen prescribing Tarceva, factors associated with prolonged survival should be taken into account.\nNo survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC negative tumours (see section 5.1).\nPancreatic cancer\nTarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer.\nWhen prescribing Tarceva, factors associated with prolonged survival should be taken into account (see sections 4.2 and 5.1).\nNo survival advantage could be shown for patients with locally advanced disease.","extracted":true,"target":{"targets":["EGFR"],"modality":"small molecule","label":"EGFR tyrosine kinase inhibitor","mechanism":"Erlotinib binds the ATP-binding site of EGFR, inhibiting its intracellular phosphorylation and downstream signaling to halt cell proliferation and induce apoptosis.","quote":"Erlotinib is an epidermal growth factor receptor/human epidermal growth factor receptor type 1 (EGFR also known as HER1) tyrosine kinase inhibitor.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/tarceva-epar-product-information_en.pdf"},"copies":[]},{"key":"temsirolimus__torisel","inn":"temsirolimus","brand":"Torisel","company":"Pfizer Europe MA EEIG","ema_product_number":"EMEA/H/C/000799","atc_code":"L01XE09","authorised":"2007-11-19","pi_updated":"2025-03-03","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/torisel","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/torisel-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/torisel-epar-product-information_de.pdf","indication_text":"Renal cell carcinoma\nTorisel is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors (see section 5.1).\nMantle cell lymphoma\nTorisel is indicated for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL) (see section 5.1).","extracted":true,"target":{"targets":["mTOR"],"modality":"small molecule","label":"mTOR inhibitor","mechanism":"Binds FKBP-12 to form a complex that inhibits mTOR, disrupting downstream translation of cell cycle regulatory proteins and impairing tumor vessel development.","quote":"Temsirolimus is a selective inhibitor of mTOR (mammalian target of rapamycin).","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/torisel-epar-product-information_en.pdf"},"copies":[]},{"key":"repotrectinib__augtyro","inn":"repotrectinib","brand":"Augtyro","company":"Bristol-Myers Squibb Pharma EEIG","ema_product_number":"EMEA/H/C/006005","atc_code":"L01EX28","authorised":"2025-01-13","pi_updated":"2025-01-28","conditional":true,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/augtyro","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/augtyro-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/augtyro-epar-product-information_de.pdf","indication_text":"AUGTYRO as monotherapy is indicated for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC).\nAUGTYRO as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with advanced solid tumours expressing a NTRK gene fusion, and  who have received a prior NTRK inhibitor, or  have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1)","extracted":true,"target":{"targets":["ROS1","TRKA","TRKB","TRKC","ALK"],"modality":"small molecule","label":"ROS1 and TRK tyrosine kinase inhibitor","mechanism":"Binds the ATP-binding pocket of ROS1, TRKA/B/C and ALK and inhibits these kinases, including solvent-front and gatekeeper resistance mutants, blocking fusion-driven signalling and proliferation.","quote":"Repotrectinib is an inhibitor of proto-oncogene tyrosine-protein kinase ROS1, the tropomyosin receptor tyrosine kinases (TRK) TRKA, TRKB, TRKC, and anaplastic lymphoma kinase (ALK) with IC50 values of 0.05 to 1.04 nM.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/augtyro-epar-product-information_en.pdf"},"copies":[]},{"key":"idelalisib__zydelig","inn":"idelalisib","brand":"Zydelig","company":"Gilead Sciences Ireland UC","ema_product_number":"EMEA/H/C/003843","atc_code":"L01XX47","authorised":"2014-09-18","pi_updated":"2024-10-21","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":true,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zydelig","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/zydelig-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/zydelig-epar-product-information_de.pdf","indication_text":"Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):\n• who have received at least one prior therapy (see section 4.4), or\n• as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies (see section 4.4).\nZydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment (see section 4.4).","extracted":true,"target":{"targets":["PI3Kδ"],"modality":"small molecule","label":"PI3Kδ inhibitor","mechanism":"Idelalisib selectively inhibits PI3Kδ by blocking ATP binding to its catalytic domain, preventing Akt phosphorylation and inducing apoptosis in malignant B-cells.","quote":"Idelalisib inhibits phosphatidylinositol 3-kinase p110δ (PI3Kδ), which is hyperactive in B-cell malignancies and is central to multiple signalling pathways that drive proliferation, survival, homing, and retention of malignant cells in lymphoid tissues and bone marrow.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/zydelig-epar-product-information_en.pdf"},"copies":[]},{"key":"aflibercept__zaltrap","inn":"aflibercept","brand":"Zaltrap","company":"Sanofi Winthrop Industrie","ema_product_number":"EMEA/H/C/002532","atc_code":"L01XX44","authorised":"2013-02-01","pi_updated":"2024-08-29","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/zaltrap","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/zaltrap-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/zaltrap-epar-product-information_de.pdf","indication_text":"ZALTRAP in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy is indicated in adults with metastatic colorectal cancer (MCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.","extracted":true,"target":{"targets":["VEGF-A","PlGF","VEGF-B"],"modality":"protein or peptide","label":"VEGF and PlGF trap fusion protein","mechanism":"Acts as a soluble decoy receptor binding VEGF-A, VEGF-B, and PlGF, preventing activation of cognate VEGF receptors to inhibit endothelial cell proliferation and tumour angiogenesis.","quote":"Aflibercept acts as a soluble decoy receptor that binds to VEGF-A, with higher affinity than its native receptors, as well as the related ligands PlGF and VEGF-B.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/zaltrap-epar-product-information_en.pdf"},"copies":[]},{"key":"toremifene__fareston","inn":"toremifene","brand":"Fareston","company":"Orion Corporation","ema_product_number":"EMEA/H/C/000091","atc_code":"L02BA02","authorised":"1996-02-14","pi_updated":"2024-07-30","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/fareston","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/fareston-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/fareston-epar-product-information_de.pdf","indication_text":"First line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients.\nFareston is not recommended for patients with estrogen receptor negative tumours.","extracted":true,"target":{"targets":["estrogen receptor"],"modality":"small molecule","label":"Selective estrogen receptor modulator","mechanism":"Binds specifically and competitively to estrogen receptors, inhibiting estrogen-induced DNA synthesis and cell replication to exert an anti-estrogenic antitumor effect.","quote":"Toremifene binds specifically to estrogen receptors, competitively with oestradiol, and inhibits estrogen-induced stimulation of DNA synthesis and cell replication.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/fareston-epar-product-information_en.pdf"},"copies":[]},{"key":"tivozanib-hydrochloride-monohydrate__fotivda","inn":"tivozanib hydrochloride monohydrate","brand":"Fotivda","company":"Recordati Netherlands B.V.","ema_product_number":"EMEA/H/C/004131","atc_code":"L01EK03","authorised":"2017-08-24","pi_updated":"2023-07-17","conditional":false,"exceptional":false,"orphan":false,"prime":false,"advanced_therapy":false,"additional_monitoring":false,"generic":false,"biosimilar":false,"epar_url":"https://www.ema.europa.eu/en/medicines/human/EPAR/fotivda","smpc_pdf":"https://www.ema.europa.eu/en/documents/product-information/fotivda-epar-product-information_en.pdf","smpc_pdf_de":"https://www.ema.europa.eu/de/documents/product-information/fotivda-epar-product-information_de.pdf","indication_text":"Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.","extracted":true,"target":{"targets":["VEGFR1","VEGFR2","VEGFR3","KIT"],"modality":"small molecule","label":"VEGFR tyrosine kinase inhibitor","mechanism":"Tivozanib selectively blocks VEGFR 1, 2, and 3 phosphorylation and activation, inhibiting endothelial cell proliferation, angiogenesis, vascular permeability, and tumour growth.","quote":"Tivozanib potently and selectively blocks all 3 vascular endothelial growth factor receptors (VEGFR) and has been shown to block various VEGF-induced biochemical and biologic responses in vitro, including VEGF-ligand-induced phosphorylation of all three VEGFR 1, 2 and 3, and proliferation of human endothelial cells.","review":false,"source":"https://www.ema.europa.eu/en/documents/product-information/fotivda-epar-product-information_en.pdf"},"copies":[]}],"indications":[{"id":"39527fa4fb76b7aa","drug_inn":"zanubrutinib","drug_brand":"Brukinsa","company":"BeOne Medicines Netherlands B. V.","atc_code":"L01EL03","approval_type":"full","advanced_therapy":false,"additional_monitoring":true,"biosimilar":false,"generic":false,"organ":"hematologic","tumor_type":"Waldenström's macroglobulinaemia","disease_stage":"any","treatment_phase":null,"line_of_therapy":"2L","biomarker_name":"none","biomarker_alteration_type":"none","biomarker_detail":"n/a","diagnostic_criterion":"n/a","scoring_system":"n/a","test_method":[],"companion_diagnostic":null,"combination":"monotherapy","prior_therapy":"At least one prior therapy","age_group":"adult","patient_eligibility":null,"notes":"","source_sentence":"BRUKINSA as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.","product_key":"zanubrutinib__brukinsa","origin":"a","flags":["no-biomarker","prior-therapy-required"],"qa":{"organ":{"jev":"hematologic","conf":1,"agrees":true},"disease_stage":{"jev":"any","conf":1,"agrees":true},"treatment_phase":{"jev":null,"conf":1,"agrees":true},"line_of_therapy":{"jev":"2L","conf":0.69,"agrees":true},"biomarker_alteration_type":{"jev":"none","conf":1,"agrees":true},"scoring_system":{"jev":"n/a","conf":1,"agrees":true},"age_group":{"jev":"adult","conf":1,"agrees":true},"test_method":{"jev":[],"conf":0.96,"agrees":true}},"decided":[],"review_fields":[]},{"id":"f7a3fb64c20bbe43","drug_inn":"zanubrutinib","drug_brand":"Brukinsa","company":"BeOne Medicines Netherlands B. V.","atc_code":"L01EL03","approval_type":"full","advanced_therapy":false,"additional_monitoring":true,"biosimilar":false,"generic":false,"organ":"hematologic","tumor_type":"Waldenström's macroglobulinaemia","disease_stage":"any","treatment_phase":null,"line_of_therapy":"1L","biomarker_name":"none","biomarker_alteration_type":"none","biomarker_detail":"n/a","diagnostic_criterion":"n/a","scoring_system":"n/a","test_method":[],"companion_diagnostic":null,"combination":"monotherapy","prior_therapy":null,"age_group":"adult","patient_eligibility":"Unsuitable for chemo-immunotherapy","notes":"","source_sentence":"BRUKINSA as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.","product_key":"zanubrutinib__brukinsa","origin":"a","flags":["no-biomarker"],"qa":{"organ":{"jev":"hematologic","conf":1,"agrees":true},"disease_stage":{"jev":"any","conf":1,"agrees":true},"treatment_phase":{"jev":null,"conf":0.94,"agrees":true},"line_of_therapy":{"jev":"any","conf":0.53,"agrees":false},"biomarker_alteration_type":{"jev":"none","conf":1,"agrees":true},"scoring_system":{"jev":"n/a","conf":1,"agrees":true},"age_group":{"jev":"adult","conf":0.99,"agrees":true},"test_method":{"jev":[],"conf":0.95,"agrees":true}},"decided":[],"review_fields":[]},{"id":"4028c527ef7dbc90","drug_inn":"zanubrutinib","drug_brand":"Brukinsa","company":"BeOne Medicines Netherlands B. V.","atc_code":"L01EL03","approval_type":"full","advanced_therapy":false,"additional_monitoring":true,"biosimilar":false,"generic":false,"organ":"hematologic","tumor_type":"marginal zone lymphoma","disease_stage":"any","treatment_phase":null,"line_of_therapy":"2L","biomarker_name":"none","biomarker_alteration_type":"none","biomarker_detail":"n/a","diagnostic_criterion":"n/a","scoring_system":"n/a","test_method":[],"companion_diagnostic":null,"combination":"monotherapy","prior_therapy":"At least one prior anti-CD20-based therapy","age_group":"adult","patient_eligibility":null,"notes":"","source_sentence":"BRUKINSA as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.","product_key":"zanubrutinib__brukinsa","origin":"a","flags":["no-biomarker","prior-therapy-required"],"qa":{"organ":{"jev":"hematologic","conf":1,"agrees":true},"disease_stage":{"jev":"any","conf":1,"agrees":true},"treatment_phase":{"jev":null,"conf":1,"agrees":true},"line_of_therapy":{"jev":"2L","conf":0.48,"agrees":true},"biomarker_alteration_type":{"jev":"none","conf":0.97,"agrees":true},"scoring_system":{"jev":"n/a","conf":1,"agrees":true},"age_group":{"jev":"adult","conf":0.99,"agrees":true},"test_method":{"jev":[],"conf":0.92,"agrees":true}},"decided":[],"review_fields":[]},{"id":"02b04e416976320f","drug_inn":"zanubrutinib","drug_brand":"Brukinsa","company":"BeOne Medicines Netherlands B. V.","atc_code":"L01EL03","approval_type":"full","advanced_therapy":false,"additional_monitoring":true,"biosimilar":false,"generic":false,"organ":"hematologic","tumor_type":"chronic lymphocytic leukemia","disease_stage":"any","treatment_phase":null,"line_of_therapy":"any","biomarker_name":"none","biomarker_alteration_type":"none","biomarker_detail":"n/a","diagnostic_criterion":"n/a","scoring_system":"n/a","test_method":[],"companion_diagnostic":null,"combination":"monotherapy","prior_therapy":null,"age_group":"adult","patient_eligibility":null,"notes":"","source_sentence":"BRUKINSA as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL).","product_key":"zanubrutinib__brukinsa","origin":"a","flags":["no-biomarker"],"qa":{"organ":{"jev":"hematologic","conf":1,"agrees":true},"disease_stage":{"jev":"any","conf":1,"agrees":true},"treatment_phase":{"jev":null,"conf":1,"agrees":true},"line_of_therapy":{"jev":"any","conf":0.85,"agrees":true},"biomarker_alteration_type":{"jev":"none","conf":1,"agrees":true},"scoring_system":{"jev":"n/a","conf":1,"agrees":true},"age_group":{"jev":"adult","conf":0.97,"agrees":true},"test_method":{"jev":[],"conf":0.95,"agrees":true}},"decided":[],"review_fields":[]},{"id":"d52aee00a04c9c4a","drug_inn":"zanubrutinib","drug_brand":"Brukinsa","company":"BeOne Medicines Netherlands B. 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