{ "entries": [ { "version": "52f637a50d", "previous": "8f49c9deb3", "date": "2026-11-05T07:19:06.777Z", "emaTimestamp": "2026-11-05T06:02:18Z", "products": [ { "key": "zanubrutinib__brukinsa", "brand": "Brukinsa", "inn": "zanubrutinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "piUpdated": [ "2026-10-07", "2026-11-04" ] } ] }, { "version": "8f49c9deb3", "previous": "8d0a6e70f7", "date": "2026-11-04T07:19:34.687Z", "emaTimestamp": "2026-11-04T06:07:45Z", "products": [ { "key": "entrectinib__rozlytrek", "brand": "Rozlytrek", "inn": "entrectinib", "status": "changed", "labelChanged": true, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "8d9e0d90b69f3f5f", "summary": "Tumour-agnostic, NTRK fusion, Any line, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "Aged older than 1 month; locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options", "to": "Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options" } ] } ], "piUpdated": [ "2025-03-27", "2026-11-03" ] } ] }, { "version": "8d0a6e70f7", "previous": "dd24201b62", "date": "2026-10-31T07:21:27.268Z", "emaTimestamp": "2026-10-31T06:02:58Z", "products": [ { "key": "pembrolizumab__keytruda", "brand": "Keytruda", "inn": "pembrolizumab", "status": "changed", "labelChanged": true, "added": [], "removed": [], "changed": [ { "id": "d5ea61cd1d9e1fe1", "summary": "Melanoma, no biomarker required, Advanced, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "Aged 12 years and older", "to": null } ] }, { "id": "8b24fa0b02faad6d", "summary": "Urothelial, no biomarker required, Neoadjuvant, early, + enfortumab vedotin", "fields": [ { "field": "patient_eligibility", "from": "Cisplatin-ineligible", "to": null } ] }, { "id": "68484b69ca7ea8fc", "summary": "Urothelial, no biomarker required, Adjuvant, early, + enfortumab vedotin", "fields": [ { "field": "patient_eligibility", "from": "Cisplatin-ineligible", "to": null } ] }, { "id": "92f37fddf562fc29", "summary": "TNBC, no biomarker required, Adjuvant, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "Neoadjuvant pembrolizumab + chemotherapy and surgery", "to": "Neoadjuvant pembrolizumab + chemotherapy and surgical resection" }, { "field": "patient_eligibility", "from": "Locally advanced, or early-stage at high risk of recurrence", "to": "Locally advanced or early-stage; high risk of recurrence" } ] }, { "id": "6952536aedce8f93", "summary": "Ovarian, PD-L1 CPS ≥ 1, 2nd line, advanced, + paclitaxel, with or without bevacizumab", "fields": [ { "field": "disease_stage", "from": "any", "to": "advanced" }, { "field": "biomarker_detail", "from": "PD-L1 CPS ≥ 1", "to": "CPS ≥ 1" }, { "field": "prior_therapy", "from": "One or two prior systemic treatment regimens", "to": "One or two prior systemic treatment regimens; platinum-resistant" }, { "field": "patient_eligibility", "from": "Platinum-resistant", "to": null } ] } ], "reworded": [ { "id": "e3da205c99944d83", "summary": "Melanoma, no biomarker required, Adjuvant, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "Aged 12 years and older; Stage IIB, IIC or III melanoma", "to": "Stage IIB, IIC or III" } ] }, { "id": "0886ac4db5a33ab9", "summary": "NSCLC, PD-L1 TPS ≥ 50%, EGFR/ALK-negative, 1st line, metastatic, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "PD-L1 TPS ≥ 50%; EGFR/ALK-negative", "to": "TPS ≥ 50%; EGFR/ALK-negative" } ] }, { "id": "31303168ce84a1a1", "summary": "NSCLC, EGFR/ALK-negative, 1st line, metastatic, + pemetrexed and platinum chemotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "No EGFR or ALK positive mutations", "to": "absence of EGFR or ALK positive mutations" } ] }, { "id": "70f046275b479c17", "summary": "NSCLC, PD-L1 TPS ≥ 1%, 2nd line, advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "PD-L1 TPS ≥ 1%", "to": "TPS ≥ 1%" }, { "field": "prior_therapy", "from": "At least one prior chemotherapy regimen; patients with EGFR or ALK positive tumour mutations should also have received targeted therapy", "to": "At least one prior chemotherapy regimen; prior targeted therapy if EGFR or ALK positive" } ] }, { "id": "b5c0956aca258c1c", "summary": "Hodgkin, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "Failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option", "to": "Failed autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT is not a treatment option" } ] }, { "id": "534311d2955e1615", "summary": "Urothelial, PD-L1 CPS ≥ 10, Advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "PD-L1 CPS ≥ 10", "to": "CPS ≥ 10" } ] }, { "id": "dd143890f5748c52", "summary": "HNSCC, PD-L1 CPS ≥ 1, Neoadjuvant, locally advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "PD-L1 CPS ≥ 1", "to": "CPS ≥ 1" } ] }, { "id": "aa9990e296bdfa0d", "summary": "HNSCC, PD-L1 CPS ≥ 1, Adjuvant, locally advanced, + radiation therapy with or without concomitant cisplatin, followed by monotherapy", "fields": [ { "field": "biomarker_detail", "from": "PD-L1 CPS ≥ 1", "to": "CPS ≥ 1" }, { "field": "combination", "from": "in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy", "to": "+ radiation therapy with or without concomitant cisplatin, followed by monotherapy" } ] }, { "id": "0008005937e89870", "summary": "HNSCC, PD-L1 CPS ≥ 1, 1st line, advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "PD-L1 CPS ≥ 1", "to": "CPS ≥ 1" } ] }, { "id": "95b0eeb9580b2bc8", "summary": "HNSCC, PD-L1 CPS ≥ 1, 1st line, advanced, + platinum and 5-fluorouracil (5-FU) chemotherapy", "fields": [ { "field": "biomarker_detail", "from": "PD-L1 CPS ≥ 1", "to": "CPS ≥ 1" } ] }, { "id": "f7b9708110dcabcd", "summary": "HNSCC, PD-L1 TPS ≥ 50%, 2nd line, advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "PD-L1 TPS ≥ 50%", "to": "TPS ≥ 50%" } ] }, { "id": "4e27ca4879d97a5a", "summary": "Endometrial, MMR/MSI deficient, Advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "Prior treatment with a platinum-containing therapy in any setting", "to": "Disease progression on or following prior treatment with a platinum-containing therapy in any setting" } ] }, { "id": "529394122bba790b", "summary": "Gastric/GEJ, MMR/MSI deficient, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "At least one prior therapy", "to": "Disease progression on or following at least one prior therapy" } ] }, { "id": "61446e491c2efff6", "summary": "Small intestine, MMR/MSI deficient, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "At least one prior therapy", "to": "Disease progression on or following at least one prior therapy" } ] }, { "id": "d48efb4d4a104f6e", "summary": "BTC, MMR/MSI deficient, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "At least one prior therapy", "to": "Disease progression on or following at least one prior therapy" } ] }, { "id": "414f1a11b964eb1e", "summary": "Oesophageal, PD-L1 CPS ≥ 10, 1st line, advanced, + platinum and fluoropyrimidine-based chemotherapy", "fields": [ { "field": "biomarker_detail", "from": "PD-L1 CPS ≥ 10", "to": "CPS ≥ 10" } ] }, { "id": "fcc7a2a88f38b5a8", "summary": "TNBC, no biomarker required, Neoadjuvant, + chemotherapy", "fields": [ { "field": "patient_eligibility", "from": "Locally advanced, or early-stage at high risk of recurrence", "to": "Locally advanced or early-stage; high risk of recurrence" } ] }, { "id": "b7a5f928db130ccc", "summary": "TNBC, PD-L1 CPS ≥ 10, 1st line, advanced, + chemotherapy", "fields": [ { "field": "biomarker_detail", "from": "PD-L1 CPS ≥ 10", "to": "CPS ≥ 10" } ] }, { "id": "6fc3430ba7cf67ad", "summary": "Endometrial, no biomarker required, Advanced, + lenvatinib", "fields": [ { "field": "prior_therapy", "from": "Prior treatment with a platinum-containing therapy in any setting", "to": "Disease progression on or following prior treatment with a platinum-containing therapy in any setting" } ] }, { "id": "42ef19dde725907d", "summary": "Cervical, PD-L1 CPS ≥ 1, Advanced, + chemotherapy with or without bevacizumab", "fields": [ { "field": "biomarker_detail", "from": "PD-L1 CPS ≥ 1", "to": "CPS ≥ 1" } ] }, { "id": "9dcb3b27afe28f8d", "summary": "Gastric/GEJ, PD-L1 CPS ≥ 1; HER2 IHC 3+ or IHC 2+/ISH-positive, 1st line, advanced, + trastuzumab, fluoropyrimidine and platinum-containing chemotherapy", "fields": [ { "field": "biomarker_detail", "from": "PD-L1 CPS ≥ 1; HER2-positive", "to": "CPS ≥ 1; HER2-positive" } ] }, { "id": "6f6a34c8f942cd71", "summary": "Gastric/GEJ, PD-L1 CPS ≥ 1, HER2-negative, 1st line, advanced, + fluoropyrimidine and platinum-containing chemotherapy", "fields": [ { "field": "biomarker_detail", "from": "PD-L1 CPS ≥ 1; HER2-negative", "to": "CPS ≥ 1; HER2-negative" } ] } ], "piUpdated": [ "2026-07-01", "2026-10-30" ] } ] }, { "version": "dd24201b62", "previous": "b8dbd587aa", "date": "2026-10-30T07:19:39.352Z", "emaTimestamp": "2026-10-30T06:02:20Z", "products": [ { "key": "avapritinib__ayvakyt", "brand": "Ayvakyt", "inn": "avapritinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "piUpdated": [ "2026-01-09", "2026-10-29" ] }, { "key": "ciltacabtagene-autoleucel__carvykti", "brand": "Carvykti", "inn": "ciltacabtagene autoleucel", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "piUpdated": [ "2026-06-01", "2026-10-29" ] }, { "key": "nivolumab__opdivo", "brand": "Opdivo", "inn": "nivolumab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "piUpdated": [ "2026-08-19", "2026-10-29" ] }, { "key": "dinutuximab-beta__qarziba-previously-dinutuximab-beta-eusa-and-dinutuximab-beta-apeiron-", "brand": "Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)", "inn": "dinutuximab beta", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "piUpdated": [ "2025-11-26", "2026-10-29" ] } ] }, { "version": "b8dbd587aa", "previous": "a0ee91f8f8", "date": "2026-10-28T07:19:52.512Z", "emaTimestamp": "2026-10-28T06:03:03Z", "products": [ { "key": "imatinib__glivec", "brand": "Glivec", "inn": "imatinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "piUpdated": [ "2025-11-12", "2026-10-27" ] } ] }, { "version": "a0ee91f8f8", "previous": "ba7a304ef0", "date": "2026-10-26T18:26:19.894Z", "emaTimestamp": "2026-10-26T18:23:38Z", "products": [ { "key": "idecabtagene-vicleucel__abecma", "brand": "Abecma", "inn": "idecabtagene vicleucel", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "03b81bf383f4b3b1", "summary": "Myeloma, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, with disease progression on the last therapy", "to": "At least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, with disease progression on the last therapy" } ] } ] }, { "key": "abiraterone-acetate__abiraterone-krka", "brand": "Abiraterone Krka", "inn": "abiraterone", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "c3f24efb752a5834", "summary": "Prostate, no biomarker required, 1st line, metastatic, + prednisone or prednisolone", "fields": [ { "field": "tumor_type", "from": "metastatic castration-resistant prostate cancer", "to": "castration-resistant prostate cancer" }, { "field": "line_of_therapy", "from": "2L", "to": "1L" }, { "field": "prior_therapy", "from": "androgen deprivation therapy", "to": "Failure of androgen deprivation therapy" }, { "field": "patient_eligibility", "from": "asymptomatic or mildly symptomatic; chemotherapy is not yet clinically indicated", "to": "Men; asymptomatic or mildly symptomatic; chemotherapy not yet clinically indicated" } ] }, { "id": "0f5e2fbba3c2700e", "summary": "Prostate, no biomarker required, 2nd line, metastatic, + prednisone or prednisolone", "fields": [ { "field": "tumor_type", "from": "metastatic castration-resistant prostate cancer", "to": "castration-resistant prostate cancer" }, { "field": "prior_therapy", "from": "docetaxel-based chemotherapy regimen", "to": "Progressed on or after a docetaxel-based chemotherapy regimen" }, { "field": "patient_eligibility", "from": null, "to": "Men" } ] } ], "reworded": [ { "id": "d6d30d214f344983", "summary": "Prostate, no biomarker required, 1st line, metastatic, + prednisone or prednisolone, and androgen deprivation therapy (ADT)", "fields": [ { "field": "tumor_type", "from": "metastatic hormone sensitive prostate cancer", "to": "hormone-sensitive prostate cancer" }, { "field": "combination", "from": "+ prednisone or prednisolone and androgen deprivation therapy (ADT)", "to": "+ prednisone or prednisolone, and androgen deprivation therapy (ADT)" }, { "field": "patient_eligibility", "from": "high risk", "to": "Men; newly diagnosed high-risk" } ] } ] }, { "key": "brentuximab-vedotin__adcetris", "brand": "Adcetris", "inn": "brentuximab vedotin", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "6be3dc07f0089939", "summary": "Hodgkin, CD30 CD30+, 3rd line+, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "CD30-positive", "to": "CD30+" }, { "field": "diagnostic_criterion", "from": "CD30-positive", "to": "CD30+" }, { "field": "prior_therapy", "from": "following ASCT, or following at least two prior therapies", "to": "Following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option" }, { "field": "patient_eligibility", "from": "when ASCT or multi-agent chemotherapy is not a treatment option", "to": null } ] }, { "id": "9d5d91cc1958ecc0", "summary": "T-cell lymphoma, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": null, "to": "Relapsed or refractory disease" } ] } ], "reworded": [ { "id": "e9bb5ce179722648", "summary": "Hodgkin, CD30 CD30+, 1st line, advanced, + doxorubicin, vinblastine and dacarbazine", "fields": [ { "field": "biomarker_detail", "from": "CD30-positive", "to": "CD30+" }, { "field": "diagnostic_criterion", "from": "CD30-positive", "to": "CD30+" } ] }, { "id": "2cb412eb791b9c6c", "summary": "Hodgkin, CD30 CD30+, 1st line, advanced, + etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone", "fields": [ { "field": "biomarker_detail", "from": "CD30-positive", "to": "CD30+" }, { "field": "diagnostic_criterion", "from": "CD30-positive", "to": "CD30+" } ] }, { "id": "f1f04714666003bf", "summary": "Hodgkin, CD30 CD30+, Consolidation, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "CD30-positive", "to": "CD30+" }, { "field": "diagnostic_criterion", "from": "CD30-positive", "to": "CD30+" }, { "field": "prior_therapy", "from": "following autologous stem cell transplant (ASCT)", "to": "Following autologous stem cell transplant (ASCT)" }, { "field": "patient_eligibility", "from": "at increased risk of relapse or progression", "to": "At increased risk of relapse or progression" } ] }, { "id": "e99157477b3642a9", "summary": "T-cell lymphoma, CD30 CD30+, 2nd line, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "CD30-positive", "to": "CD30+" }, { "field": "diagnostic_criterion", "from": "CD30-positive", "to": "CD30+" }, { "field": "prior_therapy", "from": "after at least 1 prior systemic therapy", "to": "After at least 1 prior systemic therapy" } ] } ] }, { "key": "nadofaragene-firadenovec__adstiladrin", "brand": "Adstiladrin", "inn": "nadofaragene firadenovec", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "66c4906abaa3aa18", "summary": "Urothelial, no biomarker required, Early, Monotherapy", "fields": [ { "field": "tumor_type", "from": "non-muscle invasive bladder cancer with carcinoma in situ", "to": "non-muscle invasive bladder cancer" }, { "field": "patient_eligibility", "from": "BCG-unresponsive; with or without papillary tumours", "to": "BCG-unresponsive; carcinoma in situ (CIS) with or without papillary tumours" } ] } ] }, { "key": "everolimus__afinitor", "brand": "Afinitor", "inn": "everolimus", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "aedcdeb17f6e2d48", "summary": "NET, no biomarker required, Advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "gastrointestinal neuroendocrine tumour", "to": "gastrointestinal neuroendocrine tumours" }, { "field": "patient_eligibility", "from": "well-differentiated (Grade 1 or Grade 2); non-functional; progressive disease", "to": "Well-differentiated (Grade 1 or Grade 2); non-functional; progressive disease" }, { "field": "review_fields", "from": [], "to": [ "organ" ] } ] } ], "reworded": [ { "id": "8459118b977daa0b", "summary": "Breast, Hormone receptor-positive, HER2-negative, 2nd line, advanced, + exemestane", "fields": [ { "field": "diagnostic_criterion", "from": "presence of HR expression", "to": "n/a" }, { "field": "prior_therapy", "from": "prior non-steroidal aromatase inhibitor", "to": "Recurrence or progression following a non-steroidal aromatase inhibitor" }, { "field": "patient_eligibility", "from": "postmenopausal; without symptomatic visceral disease", "to": "Postmenopausal women; without symptomatic visceral disease" } ] }, { "id": "60261e87be7bf632", "summary": "NET, no biomarker required, Advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "neuroendocrine tumour of pancreatic origin", "to": "pancreatic neuroendocrine tumours" }, { "field": "patient_eligibility", "from": "well- or moderately-differentiated; progressive disease", "to": "Well- or moderately-differentiated; progressive disease" } ] }, { "id": "e863799c2f9c27b3", "summary": "NET, no biomarker required, Advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "lung neuroendocrine tumour", "to": "lung neuroendocrine tumours" }, { "field": "patient_eligibility", "from": "well-differentiated (Grade 1 or Grade 2); non-functional; progressive disease", "to": "Well-differentiated (Grade 1 or Grade 2); non-functional; progressive disease" } ] }, { "id": "437c612a88110848", "summary": "RCC, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "VEGF-targeted therapy", "to": "Progressed on or after treatment with VEGF-targeted therapy" } ] } ] }, { "key": "niraparib-abiraterone-acetate__akeega", "brand": "Akeega", "inn": "niraparib;abiraterone", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "8c33abc055beb094", "summary": "Prostate, germline and/or somatic BRCA 1/2 mutations, 1st line, metastatic, + prednisone or prednisolone", "fields": [ { "field": "line_of_therapy", "from": "any", "to": "1L" }, { "field": "biomarker_detail", "from": "germline and/or somatic BRCA1/2 mutation", "to": "BRCA1/2 mutation (germline and/or somatic)" }, { "field": "diagnostic_criterion", "from": "presence of germline and/or somatic BRCA1/2 mutation", "to": "germline and/or somatic BRCA 1/2 mutations" }, { "field": "patient_eligibility", "from": "chemotherapy is not clinically indicated", "to": "Chemotherapy is not clinically indicated" } ] } ], "reworded": [ { "id": "417fcb5a7bce21bc", "summary": "Prostate, germline and/or somatic BRCA 1/2 mutations, Metastatic, + prednisone or prednisolone and androgen deprivation therapy (ADT)", "fields": [ { "field": "biomarker_detail", "from": "germline and/or somatic BRCA1/2 mutation", "to": "BRCA1/2 mutation (germline and/or somatic)" }, { "field": "diagnostic_criterion", "from": "presence of germline and/or somatic BRCA1/2 mutation", "to": "germline and/or somatic BRCA 1/2 mutations" }, { "field": "combination", "from": "+ prednisone or prednisolone, and androgen deprivation therapy (ADT)", "to": "+ prednisone or prednisolone and androgen deprivation therapy (ADT)" } ] } ] }, { "key": "alectinib__alecensa", "brand": "Alecensa", "inn": "alectinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "d42c65e85a6cfc6c", "summary": "NSCLC, ALK fusion, Adjuvant, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "complete tumour resection", "to": "Complete tumour resection" }, { "field": "patient_eligibility", "from": "high risk of recurrence", "to": "High risk of recurrence" } ] }, { "id": "e8c56f903dd5a751", "summary": "NSCLC, ALK fusion, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "crizotinib", "to": "Previously treated with crizotinib" } ] } ] }, { "key": "brigatinib__alunbrig", "brand": "Alunbrig", "inn": "brigatinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "52ba0388ceebac3f", "summary": "NSCLC, ALK fusion, Advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "no prior ALK inhibitor", "to": "No prior ALK inhibitor" } ] }, { "id": "cedc2eaf670aa5a2", "summary": "NSCLC, ALK fusion, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior crizotinib", "to": "Previously treated with crizotinib" } ] } ] }, { "key": "nogapendekin-alfa-inbakicept__anktiva", "brand": "Anktiva", "inn": "nogapendekin alfa inbakicept", "status": "added", "labelChanged": false, "added": [ { "id": "00977b078c5f498c", "summary": "Urothelial, no biomarker required, Early, + Bacillus Calmette-Guérin (BCG)" } ], "removed": [], "changed": [] }, { "key": "obecabtagene-autoleucel__aucatzyl", "brand": "Aucatzyl", "inn": "obecabtagene autoleucel", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "d8466144c1a019ea", "summary": "ALL, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": null, "to": "Relapsed or refractory disease" }, { "field": "patient_eligibility", "from": null, "to": "26 years of age and above" } ] } ] }, { "key": "repotrectinib__augtyro", "brand": "Augtyro", "inn": "repotrectinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "639b8fc01411e263", "summary": "Tumour-agnostic, NTRK fusion, Advanced, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "expressing a NTRK gene fusion", "to": "presence of NTRK gene fusion" }, { "field": "patient_eligibility", "from": null, "to": "Aged 12 years and older" } ] } ] }, { "key": "bevacizumab__avastin", "brand": "Avastin", "inn": "bevacizumab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "f62506c29956970c", "summary": "Breast, no biomarker required, 1st line, metastatic, + capecitabine", "fields": [ { "field": "prior_therapy", "from": "No taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months", "to": null }, { "field": "patient_eligibility", "from": "Treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate", "to": "Treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate; excluded if taxane and anthracycline-containing regimens received in the adjuvant setting within the last 12 months" }, { "field": "review_fields", "from": [], "to": [ "prior_therapy" ] } ] }, { "id": "e2722aed4d5e0035", "summary": "Ovarian, no biomarker required, 2nd line, advanced, + carboplatin and gemcitabine or carboplatin and paclitaxel", "fields": [ { "field": "prior_therapy", "from": "No prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents", "to": "Prior platinum-based therapy; no prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents" } ] } ], "reworded": [ { "id": "8ab635b8dfb4d218", "summary": "CRC, no biomarker required, Metastatic, + fluoropyrimidine-based chemotherapy", "fields": [ { "field": "tumor_type", "from": "carcinoma of the colon or rectum", "to": "colorectal carcinoma" } ] }, { "id": "b101c28634ae0694", "summary": "NSCLC, EGFR mutation, 1st line, advanced, + erlotinib", "fields": [ { "field": "biomarker_detail", "from": "activating mutation", "to": "activating mutations" }, { "field": "diagnostic_criterion", "from": "EGFR activating mutations", "to": "activating mutations" } ] }, { "id": "c4d02d262f3275cc", "summary": "RCC, no biomarker required, 1st line, advanced, + interferon alfa-2a", "fields": [ { "field": "tumor_type", "from": "renal cell cancer", "to": "renal cell carcinoma" } ] }, { "id": "4ee32c4bef6fb455", "summary": "Ovarian, no biomarker required, 2nd line, advanced, + paclitaxel, topotecan, or pegylated liposomal doxorubicin", "fields": [ { "field": "prior_therapy", "from": "No more than two prior chemotherapy regimens; no prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents", "to": "No more than two prior chemotherapy regimens; no prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents" }, { "field": "patient_eligibility", "from": "Platinum-resistant recurrent disease", "to": "Platinum-resistant disease" } ] }, { "id": "3ec8a2dc9303084e", "summary": "Cervical, no biomarker required, Advanced, + paclitaxel and cisplatin or paclitaxel and topotecan", "fields": [ { "field": "tumor_type", "from": "carcinoma of the cervix", "to": "cervical carcinoma" }, { "field": "patient_eligibility", "from": "Paclitaxel and topotecan regimen for patients who cannot receive platinum therapy", "to": "Paclitaxel and topotecan for patients who cannot receive platinum therapy" } ] } ] }, { "key": "avapritinib__ayvakyt", "brand": "Ayvakyt", "inn": "avapritinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "a7eae8751b596978", "summary": "Mastocytosis, no biomarker required, Any line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "symptomatic treatment", "to": null } ] } ], "reworded": [ { "id": "ba767aad539bbef6", "summary": "GIST, PDGFRA D842V, Advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "D842V", "to": "PDGFRA D842V mutation" } ] }, { "id": "07058bb4bceceaf6", "summary": "Mastocytosis, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least one systemic therapy", "to": "after at least one systemic therapy" } ] }, { "id": "14069ae432c57233", "summary": "Mastocytosis, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least one systemic therapy", "to": "after at least one systemic therapy" } ] }, { "id": "1dfdc2cbcd8f833a", "summary": "Mastocytosis, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least one systemic therapy", "to": "after at least one systemic therapy" } ] } ] }, { "key": "erdafitinib__balversa", "brand": "Balversa", "inn": "erdafitinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "6062873be6c42e5a", "summary": "Urothelial, susceptible FGFR3 genetic alterations, 2nd line, advanced, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "presence of susceptible FGFR3 genetic alterations", "to": "susceptible FGFR3 genetic alterations" }, { "field": "prior_therapy", "from": "at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting", "to": "At least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting" } ] } ] }, { "key": "avelumab__bavencio", "brand": "Bavencio", "inn": "avelumab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "cc0b9497a0484220", "summary": "Urothelial, no biomarker required, Maintenance, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "platinum-based chemotherapy without progression", "to": "platinum-based chemotherapy" }, { "field": "patient_eligibility", "from": null, "to": "progression-free following platinum-based chemotherapy" } ] } ] }, { "key": "tasonermin__beromun", "brand": "Beromun", "inn": "tasonermin", "status": "added", "labelChanged": false, "added": [ { "id": "1b6e9faf3371a46f", "summary": "Sarcoma, no biomarker required, Advanced, + melphalan via mild hyperthermic isolated limb perfusion (ILP)" } ], "removed": [], "changed": [] }, { "key": "inotuzumab-ozogamicin__besponsa", "brand": "Besponsa", "inn": "inotuzumab ozogamicin", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "f8d8dca9bd94dc73", "summary": "ALL, CD22-positive, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "First relapse after allo-HSCT, or first relapse with VHR disease, or second or greater relapse, or refractory disease; exhausted relevant BCR-ABL targeting treatment options if Ph+", "to": "In first relapse after allo-HSCT, or after any first relapse in VHR disease, or after a second or greater relapse, or refractory disease; patients with Ph+ disease should have exhausted relevant BCR-ABL targeting treatment options" }, { "field": "patient_eligibility", "from": null, "to": "Aged 1 year and older" } ] } ], "reworded": [ { "id": "d603c2c5126abe1a", "summary": "ALL, CD22-positive, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "For Ph+ disease, failed treatment with at least 1 tyrosine kinase inhibitor (TKI)", "to": "Relapsed or refractory disease; patients with Ph+ disease should have failed treatment with at least 1 TKI" } ] } ] }, { "key": "ropeginterferon-alfa-2b__besremi", "brand": "Besremi", "inn": "ropeginterferon alfa-2b", "status": "added", "labelChanged": false, "added": [ { "id": "35bebe7b9df5361a", "summary": "MPN, no biomarker required, Any line, Monotherapy" } ], "removed": [], "changed": [] }, { "key": "belantamab-mafodotin__blenrep", "brand": "Blenrep", "inn": "belantamab mafodotin", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "39e4b63dc4cfaf4b", "summary": "Myeloma, no biomarker required, 2nd line, + bortezomib and dexamethasone", "fields": [ { "field": "prior_therapy", "from": "at least one prior therapy", "to": "At least one prior therapy" }, { "field": "patient_eligibility", "from": null, "to": "Relapsed or refractory" } ] }, { "id": "8f7fb5c904e87c74", "summary": "Myeloma, no biomarker required, 2nd line, + pomalidomide and dexamethasone", "fields": [ { "field": "prior_therapy", "from": "at least one prior therapy including lenalidomide", "to": "At least one prior therapy including lenalidomide" }, { "field": "patient_eligibility", "from": null, "to": "Relapsed or refractory" } ] } ] }, { "key": "blinatumomab__blincyto", "brand": "Blincyto", "inn": "blinatumomab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "c5837d2263cf71f5", "summary": "ALL, CD19-positive, Philadelphia chromosome-negative, 2nd line, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "CD19 positive; Philadelphia chromosome-negative", "to": "CD19-positive; Philadelphia chromosome-negative" }, { "field": "diagnostic_criterion", "from": "CD19 positive", "to": "CD19-positive" }, { "field": "prior_therapy", "from": "relapsed or refractory", "to": null } ] }, { "id": "f4fe9d0656e7be25", "summary": "ALL, CD19-positive, Philadelphia chromosome-negative, 2nd line, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "CD19 positive; Philadelphia chromosome-negative", "to": "CD19-positive; Philadelphia chromosome-negative" }, { "field": "diagnostic_criterion", "from": "CD19 positive", "to": "CD19-positive" }, { "field": "prior_therapy", "from": "at least two prior therapies, or prior allogeneic haematopoietic stem cell transplantation", "to": "At least two prior therapies, or prior allogeneic haematopoietic stem cell transplantation" }, { "field": "patient_eligibility", "from": null, "to": "Aged 1 month or older" } ] }, { "id": "e8f44fa4d720395a", "summary": "ALL, CD19-positive, Philadelphia chromosome-negative, Consolidation, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "CD19 positive; Philadelphia chromosome-negative", "to": "CD19-positive; Philadelphia chromosome-negative" }, { "field": "diagnostic_criterion", "from": "CD19 positive", "to": "CD19-positive" }, { "field": "prior_therapy", "from": "first relapse", "to": null }, { "field": "patient_eligibility", "from": "high-risk", "to": "Aged 1 month or older; high-risk" } ] } ], "reworded": [ { "id": "890f25bf4bf33a6a", "summary": "ALL, CD19-positive, Philadelphia chromosome-positive, 3rd line+, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "CD19 positive; Philadelphia chromosome-positive", "to": "CD19-positive; Philadelphia chromosome-positive" }, { "field": "diagnostic_criterion", "from": "CD19 positive and Philadelphia chromosome-positive", "to": "CD19-positive" }, { "field": "prior_therapy", "from": "failed treatment with at least 2 tyrosine kinase inhibitors (TKIs)", "to": "Failed treatment with at least 2 tyrosine kinase inhibitors (TKIs)" }, { "field": "patient_eligibility", "from": "no alternative treatment options", "to": "No alternative treatment options" } ] }, { "id": "a3cba8269ea8a413", "summary": "ALL, CD19-positive, Philadelphia chromosome-negative, 1st line, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "CD19 positive; Philadelphia chromosome-negative; MRD ≥ 0.1%", "to": "CD19-positive; Philadelphia chromosome-negative" }, { "field": "diagnostic_criterion", "from": "CD19 positive and MRD ≥ 0.1%", "to": "CD19-positive" }, { "field": "patient_eligibility", "from": "in first or second complete remission with minimal residual disease (MRD) ≥ 0.1%", "to": "In first or second complete remission with minimal residual disease (MRD) ≥ 0.1%" } ] }, { "id": "eb03f97621c914dc", "summary": "ALL, CD19-positive, Philadelphia chromosome-negative, Consolidation, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "CD19 positive; Philadelphia chromosome-negative", "to": "CD19-positive; Philadelphia chromosome-negative" }, { "field": "diagnostic_criterion", "from": "CD19 positive", "to": "CD19-positive" } ] } ] }, { "key": "bosutinib__bosulif", "brand": "Bosulif", "inn": "bosutinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "7f24d4b8601040cf", "summary": "CML, Philadelphia chromosome / BCR::ABL1 translocation, 1st line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "chronic phase Philadelphia chromosome-positive chronic myelogenous leukaemia", "to": "chronic myelogenous leukaemia (chronic phase)" }, { "field": "biomarker_detail", "from": "Philadelphia chromosome-positive (Ph+)", "to": "Ph+ (Philadelphia chromosome-positive)" }, { "field": "diagnostic_criterion", "from": "presence of t(9;22) / BCR::ABL1 fusion", "to": "presence of Philadelphia chromosome / BCR::ABL1 translocation" }, { "field": "patient_eligibility", "from": null, "to": "Aged 6 years and older" } ] } ], "reworded": [ { "id": "d56012e7506928c9", "summary": "CML, Philadelphia chromosome / BCR::ABL1 translocation, 2nd line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "chronic phase Philadelphia chromosome-positive chronic myelogenous leukaemia", "to": "chronic myelogenous leukaemia (chronic phase)" }, { "field": "biomarker_detail", "from": "Philadelphia chromosome-positive (Ph+)", "to": "Ph+ (Philadelphia chromosome-positive)" }, { "field": "diagnostic_criterion", "from": "presence of t(9;22) / BCR::ABL1 fusion", "to": "presence of Philadelphia chromosome / BCR::ABL1 translocation" }, { "field": "prior_therapy", "from": "one or more tyrosine kinase inhibitor(s)", "to": "Previously treated with one or more tyrosine kinase inhibitor(s)" }, { "field": "patient_eligibility", "from": "imatinib, nilotinib and dasatinib are not considered appropriate treatment options", "to": "Aged 6 years and older; imatinib, nilotinib and dasatinib are not considered appropriate treatment options" } ] }, { "id": "d70a6d433b625011", "summary": "CML, Philadelphia chromosome / BCR::ABL1 translocation, 2nd line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "accelerated phase or blast phase Philadelphia chromosome-positive chronic myelogenous leukaemia", "to": "chronic myelogenous leukaemia (accelerated or blast phase)" }, { "field": "biomarker_detail", "from": "Philadelphia chromosome-positive (Ph+)", "to": "Ph+ (Philadelphia chromosome-positive)" }, { "field": "diagnostic_criterion", "from": "presence of t(9;22) / BCR::ABL1 fusion", "to": "presence of Philadelphia chromosome / BCR::ABL1 translocation" }, { "field": "prior_therapy", "from": "one or more tyrosine kinase inhibitor(s)", "to": "Previously treated with one or more tyrosine kinase inhibitor(s)" }, { "field": "patient_eligibility", "from": "imatinib, nilotinib and dasatinib are not considered appropriate treatment options", "to": "Imatinib, nilotinib and dasatinib are not considered appropriate treatment options" } ] } ] }, { "key": "encorafenib__braftovi", "brand": "Braftovi", "inn": "encorafenib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "86ffa9f5f295e558", "summary": "Melanoma, BRAF V600, Advanced, + binimetinib", "fields": [ { "field": "diagnostic_criterion", "from": "presence of BRAF V600 mutation", "to": "BRAF V600 mutation" } ] }, { "id": "941187f62f3e75de", "summary": "CRC, BRAF V600E, 2nd line, metastatic, + cetuximab", "fields": [ { "field": "diagnostic_criterion", "from": "presence of BRAF V600E mutation", "to": "BRAF V600E mutation" } ] }, { "id": "35727b5d3f5ecd7f", "summary": "CRC, BRAF V600E, 1st line, metastatic, + cetuximab and FOLFOX", "fields": [ { "field": "diagnostic_criterion", "from": "presence of BRAF V600E mutation", "to": "BRAF V600E mutation" } ] }, { "id": "b3629c06056dc3db", "summary": "NSCLC, BRAF V600E, Advanced, + binimetinib", "fields": [ { "field": "diagnostic_criterion", "from": "presence of BRAF V600E mutation", "to": "BRAF V600E mutation" } ] } ] }, { "key": "lisocabtagene-maraleucel__breyanzi", "brand": "Breyanzi", "inn": "lisocabtagene maraleucel", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "ea70adf8f3c748fe", "summary": "LBCL/DLBCL, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "diffuse large B-cell lymphoma", "to": "diffuse large B-cell lymphoma (DLBCL)" }, { "field": "prior_therapy", "from": "first-line chemoimmunotherapy", "to": "Relapsed within 12 months from completion of, or refractory to, first-line chemoimmunotherapy" }, { "field": "patient_eligibility", "from": "relapsed within 12 months from completion of, or refractory to, first-line chemoimmunotherapy", "to": null } ] }, { "id": "5de932ec4e9ce13a", "summary": "LBCL/DLBCL, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "high grade B-cell lymphoma", "to": "high grade B-cell lymphoma (HGBCL)" }, { "field": "prior_therapy", "from": "first-line chemoimmunotherapy", "to": "Relapsed within 12 months from completion of, or refractory to, first-line chemoimmunotherapy" }, { "field": "patient_eligibility", "from": "relapsed within 12 months from completion of, or refractory to, first-line chemoimmunotherapy", "to": null } ] }, { "id": "2e846c07e1afe126", "summary": "LBCL/DLBCL, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "primary mediastinal large B-cell lymphoma", "to": "primary mediastinal large B-cell lymphoma (PMBCL)" }, { "field": "prior_therapy", "from": "first-line chemoimmunotherapy", "to": "Relapsed within 12 months from completion of, or refractory to, first-line chemoimmunotherapy" }, { "field": "patient_eligibility", "from": "relapsed within 12 months from completion of, or refractory to, first-line chemoimmunotherapy", "to": null } ] }, { "id": "be17d81fd9c53a6d", "summary": "FL, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "follicular lymphoma grade 3B", "to": "follicular lymphoma grade 3B (FL3B)" }, { "field": "prior_therapy", "from": "first-line chemoimmunotherapy", "to": "Relapsed within 12 months from completion of, or refractory to, first-line chemoimmunotherapy" }, { "field": "patient_eligibility", "from": "relapsed within 12 months from completion of, or refractory to, first-line chemoimmunotherapy", "to": null } ] } ], "reworded": [ { "id": "1b2e154c45f9977d", "summary": "LBCL/DLBCL, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "tumor_type", "from": "diffuse large B-cell lymphoma", "to": "diffuse large B-cell lymphoma (DLBCL)" }, { "field": "prior_therapy", "from": "two or more lines of systemic therapy", "to": "Two or more lines of systemic therapy" } ] }, { "id": "cabef418a1fb7586", "summary": "LBCL/DLBCL, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "tumor_type", "from": "primary mediastinal large B-cell lymphoma", "to": "primary mediastinal large B-cell lymphoma (PMBCL)" }, { "field": "prior_therapy", "from": "two or more lines of systemic therapy", "to": "Two or more lines of systemic therapy" } ] }, { "id": "687806c657684061", "summary": "FL, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "tumor_type", "from": "follicular lymphoma grade 3B", "to": "follicular lymphoma grade 3B (FL3B)" }, { "field": "prior_therapy", "from": "two or more lines of systemic therapy", "to": "Two or more lines of systemic therapy" } ] }, { "id": "a830d9e64f19dc44", "summary": "FL, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "tumor_type", "from": "follicular lymphoma", "to": "follicular lymphoma (FL)" }, { "field": "prior_therapy", "from": "two or more lines of systemic therapy", "to": "Two or more lines of systemic therapy" } ] }, { "id": "05cea983401ba352", "summary": "MCL, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "tumor_type", "from": "mantle cell lymphoma", "to": "mantle cell lymphoma (MCL)" }, { "field": "prior_therapy", "from": "at least two lines of systemic therapy including a Bruton's tyrosine kinase (BTK) inhibitor", "to": "At least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor" } ] } ] }, { "key": "zanubrutinib__brukinsa", "brand": "Brukinsa", "inn": "zanubrutinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "39527fa4fb76b7aa", "summary": "Waldenström, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least one prior therapy", "to": "At least one prior therapy" } ] }, { "id": "f7a3fb64c20bbe43", "summary": "Waldenström, no biomarker required, 1st line, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "unsuitable for chemo-immunotherapy", "to": "Unsuitable for chemo-immunotherapy" } ] }, { "id": "4028c527ef7dbc90", "summary": "MZL, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least one prior anti-CD20-based therapy", "to": "At least one prior anti-CD20-based therapy" } ] }, { "id": "d52aee00a04c9c4a", "summary": "FL, no biomarker required, 3rd line+, + obinutuzumab", "fields": [ { "field": "prior_therapy", "from": "at least two prior systemic therapies", "to": "At least two prior systemic therapies" }, { "field": "patient_eligibility", "from": "refractory or relapsed", "to": "Relapsed or refractory" } ] } ] }, { "key": "cabozantinib__cabometyx", "brand": "Cabometyx", "inn": "cabozantinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "a3e065fc368d5c09", "summary": "NET, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "well differentiated extra-pancreatic neuroendocrine tumour", "to": "pancreatic neuroendocrine tumours" }, { "field": "organ", "from": "other", "to": "pancreas" }, { "field": "prior_therapy", "from": "at least one prior systemic therapy other than somatostatin analogues", "to": "progressed following at least one prior systemic therapy other than somatostatin analogues" } ] }, { "id": "af6b469377d63dff", "summary": "NET, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "well differentiated pancreatic neuroendocrine tumour", "to": "extra-pancreatic neuroendocrine tumours" }, { "field": "organ", "from": "pancreas", "to": "other" }, { "field": "prior_therapy", "from": "at least one prior systemic therapy other than somatostatin analogues", "to": "progressed following at least one prior systemic therapy other than somatostatin analogues" } ] } ], "reworded": [ { "id": "820f4b143f034fad", "summary": "HCC, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior sorafenib", "to": "previously been treated with sorafenib" } ] }, { "id": "33355c1e1830c040", "summary": "Thyroid, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior systemic therapy", "to": "progressed during or after prior systemic therapy" } ] } ] }, { "key": "acalabrutinib__calquence", "brand": "Calquence", "inn": "acalabrutinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "03577ecf3b6d95e5", "summary": "CLL, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least one prior therapy", "to": "At least one prior therapy" } ] } ] }, { "key": "leuprorelin__camcevi", "brand": "Camcevi", "inn": "leuprorelin", "status": "added", "labelChanged": false, "added": [ { "id": "3abe986492330dfd", "summary": "Prostate, no biomarker required, Advanced, Monotherapy" }, { "id": "910cbcbe8dcca803", "summary": "Prostate, no biomarker required, Any line, + radiotherapy" } ], "removed": [], "changed": [] }, { "key": "vandetanib__caprelsa", "brand": "Caprelsa", "inn": "vandetanib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "7f7c35bd62c716ba", "summary": "Thyroid, RET mutation, Advanced, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "presence of RET mutation", "to": "RET mutation" }, { "field": "patient_eligibility", "from": "aggressive and symptomatic disease", "to": "aggressive and symptomatic disease; aged 5 years and older" } ] } ] }, { "key": "ciltacabtagene-autoleucel__carvykti", "brand": "Carvykti", "inn": "ciltacabtagene autoleucel", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "9e1efa10a310cd23", "summary": "Myeloma, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least one prior therapy including an immunomodulatory agent and a proteasome inhibitor; disease progression on the last therapy", "to": "At least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor; disease progression on the last therapy; refractory to lenalidomide" }, { "field": "patient_eligibility", "from": "refractory to lenalidomide", "to": "Refractory to lenalidomide" } ] } ] }, { "key": "sugemalimab__cejemly", "brand": "Cejemly", "inn": "sugemalimab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "7e77ba44a76926d4", "summary": "NSCLC, PD-L1 expression ≥ 1%, EGFR/ALK/ROS1-negative, Consolidation, locally advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "PD-L1 expression on ≥ 1% of tumour cells; no sensitising EGFR mutations, or ALK, ROS1 genomic tumour aberrations", "to": "PD-L1 expression ≥ 1%; EGFR/ALK/ROS1-negative" }, { "field": "diagnostic_criterion", "from": "≥ 1% of tumour cells", "to": "PD-L1 on ≥ 1% of tumour cells" }, { "field": "patient_eligibility", "from": "unresectable", "to": null }, { "field": "review_fields", "from": [ "disease_stage" ], "to": [] } ] } ] }, { "key": "glofitamab__columvi", "brand": "Columvi", "inn": "glofitamab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "15a565b6ecdb10d7", "summary": "LBCL/DLBCL, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "two or more lines of systemic therapy", "to": "after two or more lines of systemic therapy" } ] } ] }, { "key": "cobimetinib__cotellic", "brand": "Cotellic", "inn": "cobimetinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "65e50aa9aa3b8d3d", "summary": "Melanoma, BRAF V600, Advanced, + vemurafenib", "fields": [ { "field": "diagnostic_criterion", "from": "presence of BRAF V600 mutation", "to": "V600 mutation" } ] } ] }, { "key": "ramucirumab__cyramza", "brand": "Cyramza", "inn": "ramucirumab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "ab5db4cfc5383db5", "summary": "CRC, no biomarker required, 2nd line, metastatic, + FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil)", "fields": [ { "field": "combination", "from": "+ FOLFIRI", "to": "+ FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil)" }, { "field": "prior_therapy", "from": "prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine", "to": "bevacizumab, oxaliplatin and a fluoropyrimidine" } ] } ], "reworded": [ { "id": "ff3c7e3badb506cc", "summary": "Gastric/GEJ, no biomarker required, 2nd line, advanced, + paclitaxel", "fields": [ { "field": "prior_therapy", "from": "prior platinum and fluoropyrimidine chemotherapy", "to": "platinum and fluoropyrimidine chemotherapy" } ] }, { "id": "a0e8114f48c82ea2", "summary": "Gastric/GEJ, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior platinum or fluoropyrimidine chemotherapy", "to": "platinum or fluoropyrimidine chemotherapy" }, { "field": "patient_eligibility", "from": "treatment in combination with paclitaxel is not appropriate", "to": "for whom treatment in combination with paclitaxel is not appropriate" } ] }, { "id": "6fef2f02d5dc047f", "summary": "NSCLC, EGFR mutation, 1st line, metastatic, + erlotinib", "fields": [ { "field": "diagnostic_criterion", "from": "activating mutations", "to": "presence of activating EGFR mutation" } ] }, { "id": "e96f6fe24ad4b96b", "summary": "HCC, serum AFP ≥ 400 ng/ml, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "previously treated with sorafenib", "to": "sorafenib" } ] } ] }, { "key": "daratumumab__darzalex", "brand": "Darzalex", "inn": "daratumumab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "02bf742ff68567c8", "summary": "Myeloma, no biomarker required, 1st line, + lenalidomide and dexamethasone, or bortezomib, melphalan and prednisone", "fields": [ { "field": "combination", "from": "+ lenalidomide and dexamethasone or bortezomib, melphalan and prednisone", "to": "+ lenalidomide and dexamethasone, or bortezomib, melphalan and prednisone" }, { "field": "patient_eligibility", "from": "ineligible for autologous stem cell transplant", "to": "Ineligible for autologous stem cell transplant" } ] }, { "id": "92829f187f44f17b", "summary": "Myeloma, no biomarker required, 1st line, + bortezomib, thalidomide and dexamethasone", "fields": [ { "field": "patient_eligibility", "from": "eligible for autologous stem cell transplant", "to": "Eligible for autologous stem cell transplant" } ] }, { "id": "12733008b33a9a3f", "summary": "Myeloma, no biomarker required, 2nd line, + lenalidomide and dexamethasone, or bortezomib and dexamethasone", "fields": [ { "field": "prior_therapy", "from": "at least one prior therapy", "to": "At least one prior therapy" } ] }, { "id": "10d7e1a031eb41ef", "summary": "Myeloma, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior therapy included a proteasome inhibitor and an immunomodulatory agent, with disease progression on the last therapy", "to": "Prior therapy included a proteasome inhibitor and an immunomodulatory agent, and demonstrated disease progression on the last therapy" } ] }, { "id": "36671dc7cd2ec24e", "summary": "Myeloma, no biomarker required, 2nd line, + pomalidomide and dexamethasone", "fields": [ { "field": "prior_therapy", "from": "one prior therapy containing a proteasome inhibitor and lenalidomide (lenalidomide-refractory), or at least two prior therapies that included lenalidomide and a proteasome inhibitor with disease progression on or after the last therapy", "to": "One prior therapy containing a proteasome inhibitor and lenalidomide with lenalidomide refractoriness, or at least two prior therapies including lenalidomide and a proteasome inhibitor with disease progression on or after the last therapy" } ] }, { "id": "9bc20e35ffe9790b", "summary": "Myeloma, no biomarker required, Any line, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "high risk of developing multiple myeloma", "to": "High risk of developing multiple myeloma" } ] }, { "id": "3f4774f669d4402c", "summary": "AL amyloidosis, no biomarker required, 1st line, + cyclophosphamide, bortezomib and dexamethasone", "fields": [ { "field": "tumor_type", "from": "systemic AL amyloidosis", "to": "systemic light chain (AL) amyloidosis" } ] } ] }, { "key": "dasatinib__dasatinib-accord-healthcare", "brand": "Dasatinib Accord Healthcare", "inn": "dasatinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "218ca8b70974cba4", "summary": "CML, BCR::ABL1 fusion, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "resistance or intolerance to prior therapy including imatinib", "to": "Resistance or intolerance to prior therapy including imatinib" }, { "field": "patient_eligibility", "from": "chronic, accelerated or blast phase", "to": "Chronic, accelerated or blast phase" }, { "field": "review_fields", "from": [], "to": [ "biomarker_alteration_type", "biomarker_name" ] } ] } ], "reworded": [ { "id": "4f3e2dd327080cdc", "summary": "CML, Philadelphia chromosome positive (Ph+), 1st line, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "chronic phase", "to": "Chronic phase" } ] }, { "id": "653341d59e00a6ab", "summary": "ALL, BCR::ABL1 fusion, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "resistance or intolerance to prior therapy", "to": "Resistance or intolerance to prior therapy" } ] }, { "id": "2af0283923a3a348", "summary": "CML, BCR::ABL1 fusion, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "resistance or intolerance to prior therapy", "to": "Resistance or intolerance to prior therapy" }, { "field": "patient_eligibility", "from": "lymphoid blast phase", "to": "Lymphoid blast phase" } ] }, { "id": "fb3fc53cf51b6304", "summary": "CML, BCR::ABL1 fusion, 1st line, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "chronic phase", "to": "Chronic phase" } ] }, { "id": "2a05933564da8e75", "summary": "CML, BCR::ABL1 fusion, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "resistance or intolerance to prior therapy including imatinib", "to": "Resistant or intolerant to prior therapy including imatinib" }, { "field": "patient_eligibility", "from": "chronic phase", "to": "Chronic phase" } ] } ] }, { "key": "datopotamab-deruxtecan__datroway", "brand": "Datroway", "inn": "datopotamab deruxtecan", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "7841ee03015d5d31", "summary": "TNBC, triple-negative (ER-negative, PR-negative, HER2-negative), 1st line, advanced, Monotherapy", "fields": [ { "field": "biomarker_name", "from": "none", "to": "ER/PR/HER2" }, { "field": "biomarker_alteration_type", "from": "none", "to": "wild-type-required" }, { "field": "biomarker_detail", "from": "n/a", "to": "triple-negative (ER-negative, PR-negative, HER2-negative)" }, { "field": "diagnostic_criterion", "from": "n/a", "to": "ER-negative, PR-negative, HER2-negative" }, { "field": "patient_eligibility", "from": "not candidates for PD-1/PD-L1 inhibitor therapy", "to": "Not candidates for PD-1/PD-L1 inhibitor therapy" } ] } ], "reworded": [ { "id": "a8a47fe63004aff3", "summary": "Breast, Hormone receptor-positive, HER2-negative, 2nd line, advanced, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "n/a", "to": "hormone receptor (HR)-positive; HER2-negative" } ] } ] }, { "key": "glasdegib__daurismo", "brand": "Daurismo", "inn": "glasdegib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "cdf354de2cd208e4", "summary": "AML, no biomarker required, 1st line, + low-dose cytarabine", "fields": [ { "field": "tumor_type", "from": "acute myeloid leukaemia", "to": "acute myeloid leukaemia (AML)" }, { "field": "patient_eligibility", "from": "not candidates for standard induction chemotherapy", "to": "Not candidates for standard induction chemotherapy" } ] } ] }, { "key": "tabelecleucel__ebvallo", "brand": "Ebvallo", "inn": "tabelecleucel", "status": "added", "labelChanged": false, "added": [ { "id": "6d385f5d0004800c", "summary": "PTLD, EBV-positive, 2nd line, Monotherapy" } ], "removed": [], "changed": [] }, { "key": "mirvetuximab-soravtansine__elahere", "brand": "Elahere", "inn": "mirvetuximab soravtansine", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "26ffc3392b29b358", "summary": "Ovarian, FRα FRα-positive, 2nd line, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "folate receptor-alpha (FRα) positive", "to": "FRα-positive" }, { "field": "diagnostic_criterion", "from": "folate receptor-alpha (FRα) positive", "to": "FRα-positive" }, { "field": "prior_therapy", "from": "one to three prior systemic treatment regimens", "to": "1 to 3 prior systemic treatment regimens" } ] } ] }, { "key": "elranatamab__elrexfio", "brand": "Elrexfio", "inn": "elranatamab", "status": "added", "labelChanged": false, "added": [ { "id": "932271ef2d28aed3", "summary": "Myeloma, no biomarker required, 3rd line+, Monotherapy" } ], "removed": [], "changed": [] }, { "key": "elotuzumab__empliciti", "brand": "Empliciti", "inn": "elotuzumab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "2f01eb3b87a39429", "summary": "Myeloma, no biomarker required, 3rd line+, + pomalidomide and dexamethasone", "fields": [ { "field": "prior_therapy", "from": "at least two prior therapies including lenalidomide and a proteasome inhibitor, with disease progression on the last therapy", "to": "At least two prior therapies including lenalidomide and a proteasome inhibitor, with disease progression on the last therapy" }, { "field": "patient_eligibility", "from": "relapsed and refractory", "to": null } ] } ], "reworded": [ { "id": "46b4a1ad05361f24", "summary": "Myeloma, no biomarker required, 2nd line, + lenalidomide and dexamethasone", "fields": [ { "field": "prior_therapy", "from": "at least one prior therapy", "to": "At least one prior therapy" } ] } ] }, { "key": "trastuzumab-deruxtecan__enhertu", "brand": "Enhertu", "inn": "trastuzumab deruxtecan", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "c7b944eaede09e7b", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "one or more prior anti-HER2-based regimens", "to": "One or more prior anti-HER2-based regimens" } ] }, { "id": "5803a6867784e39e", "summary": "Breast, IHC 1+ or IHC 2+/ISH-negative or IHC 0 with membrane staining (faint, incomplete, ≤10% of tumour cells), HER2-low or HER2-ultralow, HR-positive, 2nd line, advanced, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "IHC 1+ or IHC 2+/ISH-negative, or IHC 0 with membrane staining (faint, incomplete, ≤10% of tumour cells)", "to": "IHC 1+ or IHC 2+/ISH-negative or IHC 0 with membrane staining (faint, incomplete, ≤10% of tumour cells)" }, { "field": "prior_therapy", "from": "at least one endocrine therapy in the metastatic setting", "to": "At least one endocrine therapy in the metastatic setting" }, { "field": "patient_eligibility", "from": "not considered suitable for endocrine therapy as the next line of treatment", "to": "Not considered suitable for endocrine therapy as the next line of treatment" } ] }, { "id": "3a78a08250c32983", "summary": "Breast, IHC 1+ or IHC 2+/ISH-negative, HER2-low, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy", "to": "Prior chemotherapy in the metastatic setting or disease recurrence during or within 6 months of completing adjuvant chemotherapy" } ] }, { "id": "e1a227ed75d86d41", "summary": "NSCLC, HER2 mutation, 2nd line, advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "activating HER2 (ERBB2) mutation", "to": "Activating HER2 (ERBB2) mutation" }, { "field": "diagnostic_criterion", "from": "presence of activating HER2 (ERBB2) mutation", "to": "Activating HER2 (ERBB2) mutation" }, { "field": "prior_therapy", "from": "platinum-based chemotherapy with or without immunotherapy", "to": "Platinum-based chemotherapy with or without immunotherapy" } ] }, { "id": "398d60c68f820057", "summary": "Gastric/GEJ, HER2 IHC 3+ or IHC 2+/ISH-positive, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior trastuzumab-based regimen", "to": "Prior trastuzumab-based regimen" } ] }, { "id": "24e57684c558acff", "summary": "Tumour-agnostic, HER2-positive (IHC 3+), 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior treatment", "to": "Prior treatment" }, { "field": "patient_eligibility", "from": "no satisfactory treatment options", "to": "No satisfactory treatment options" } ] } ] }, { "key": "cetuximab__erbitux", "brand": "Erbitux", "inn": "cetuximab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "ce7d425b59e42efe", "summary": "CRC, RAS wild-type, EGFR-expressing, Metastatic, + irinotecan-based chemotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "RAS wild-type, EGFR-expressing", "to": "RAS wild-type; EGFR-expressing" } ] }, { "id": "51e7f11d5698f8d1", "summary": "CRC, RAS wild-type, EGFR-expressing, 1st line, metastatic, + FOLFOX", "fields": [ { "field": "diagnostic_criterion", "from": "RAS wild-type, EGFR-expressing", "to": "RAS wild-type; EGFR-expressing" } ] }, { "id": "928b49935b9f7100", "summary": "CRC, RAS wild-type, EGFR-expressing, 3rd line+, metastatic, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "RAS wild-type, EGFR-expressing", "to": "RAS wild-type; EGFR-expressing" }, { "field": "prior_therapy", "from": "oxaliplatin- and irinotecan-based therapy", "to": "failed oxaliplatin- and irinotecan-based therapy" } ] } ] }, { "key": "vismodegib__erivedge", "brand": "Erivedge", "inn": "vismodegib", "status": "changed", "labelChanged": false, "added": [ { "id": "d3c25ee056d2a6b4", "summary": "BCC, no biomarker required, Metastatic, Monotherapy" } ], "removed": [], "changed": [ { "id": "c0cd29d222a02136", "summary": "BCC, no biomarker required, Locally advanced, Monotherapy", "fields": [ { "field": "disease_stage", "from": "advanced", "to": "locally-advanced" }, { "field": "patient_eligibility", "from": "symptomatic metastatic disease or locally advanced disease inappropriate for surgery or radiotherapy", "to": "inappropriate for surgery or radiotherapy" } ] } ] }, { "key": "apalutamide__erleada", "brand": "Erleada", "inn": "apalutamide", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "f2bce8ad6f8b2e58", "summary": "Prostate, no biomarker required, Metastatic, + androgen deprivation therapy (ADT)", "fields": [ { "field": "patient_eligibility", "from": null, "to": "Men" } ] } ], "reworded": [ { "id": "5f31e146bf4afdfb", "summary": "Prostate, no biomarker required, Locally advanced, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "high risk of developing metastatic disease", "to": "Men; high risk of developing metastatic disease" } ] } ] }, { "key": "camizestrant__etcamah", "brand": "Etcamah", "inn": "camizestrant", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "3db25b546636ec2c", "summary": "Breast, ESR1 mutation, ER-positive, HER2-negative, 1st line, advanced, + a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib)", "fields": [ { "field": "diagnostic_criterion", "from": "detection of ESR1-mutation", "to": "detection of ESR1 mutation" }, { "field": "prior_therapy", "from": "First-line endocrine therapy in combination with a CDK4/6 inhibitor", "to": "During first-line endocrine therapy + CDK4/6 inhibitor, before progression" }, { "field": "patient_eligibility", "from": "Without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor; pre- or peri-menopausal women and men should be combined with an LHRH agonist or antagonist", "to": "In pre- or peri-menopausal women and in men, should be combined with a LHRH agonist or antagonist" } ] } ] }, { "key": "mirdametinib__ezmekly", "brand": "Ezmekly", "inn": "mirdametinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "08bb1ad9073a4713", "summary": "NF1-PN, no biomarker required, Any line, Monotherapy", "fields": [ { "field": "disease_stage", "from": "advanced", "to": "any" }, { "field": "patient_eligibility", "from": "neurofibromatosis type 1 (NF1); symptomatic; inoperable", "to": "Symptomatic; inoperable; neurofibromatosis type 1; aged 2 years and above" }, { "field": "review_fields", "from": [ "organ" ], "to": [] } ] } ] }, { "key": "toremifene__fareston", "brand": "Fareston", "inn": "toremifene", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "35bb9664b3a5c7f0", "summary": "Breast, Hormone receptor-positive, 1st line, metastatic, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "hormone-dependent; ER-positive", "to": "ER-positive" }, { "field": "diagnostic_criterion", "from": "hormone-dependent; not estrogen receptor negative", "to": "n/a" }, { "field": "patient_eligibility", "from": "postmenopausal", "to": "Postmenopausal" } ] } ] }, { "key": "panobinostat__farydak", "brand": "Farydak", "inn": "panobinostat", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "f0d0cae2b9caf8c6", "summary": "Myeloma, no biomarker required, 3rd line+, + bortezomib and dexamethasone", "fields": [ { "field": "prior_therapy", "from": "at least two prior regimens including bortezomib and an immunomodulatory agent", "to": "At least two prior regimens including bortezomib and an immunomodulatory agent" } ] } ] }, { "key": "fulvestrant__faslodex", "brand": "Faslodex", "inn": "fulvestrant", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "20be1d3a3ac34d81", "summary": "Breast, Hormone receptor-positive, 1st line, advanced, Monotherapy", "fields": [ { "field": "line_of_therapy", "from": "any", "to": "1L" }, { "field": "prior_therapy", "from": null, "to": "No prior endocrine therapy" }, { "field": "patient_eligibility", "from": "postmenopausal", "to": "Postmenopausal women" } ] }, { "id": "6e6afcfcfa72665b", "summary": "Breast, Hormone receptor-positive, HER2-negative, 2nd line, advanced, + palbociclib", "fields": [ { "field": "diagnostic_criterion", "from": "HR-positive, HER2-negative", "to": "HR-positive; HER2-negative" }, { "field": "prior_therapy", "from": "prior endocrine therapy", "to": "Prior endocrine therapy" }, { "field": "patient_eligibility", "from": null, "to": "Women; In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a LHRH agonist" } ] } ], "reworded": [ { "id": "4991b3f8b319e68b", "summary": "Breast, Hormone receptor-positive, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy", "to": "Disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy" }, { "field": "patient_eligibility", "from": "postmenopausal", "to": "Postmenopausal women" } ] } ] }, { "key": "dabrafenib__finlee", "brand": "Finlee", "inn": "dabrafenib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "d941077c42c56cca", "summary": "Glioma, BRAF V600E, Any line, + trametinib", "fields": [ { "field": "line_of_therapy", "from": "2L", "to": "any" }, { "field": "biomarker_detail", "from": "V600E", "to": "BRAF V600E" }, { "field": "prior_therapy", "from": "at least one prior radiation and/or chemotherapy treatment", "to": "At least one prior radiation and/or chemotherapy treatment" }, { "field": "patient_eligibility", "from": null, "to": "Aged 1 year and older" }, { "field": "review_fields", "from": [ "line_of_therapy" ], "to": [] } ] } ], "reworded": [ { "id": "2fd5b8d49a1e4c8f", "summary": "Glioma, BRAF V600E, Any line, + trametinib", "fields": [ { "field": "biomarker_detail", "from": "V600E", "to": "BRAF V600E" }, { "field": "patient_eligibility", "from": "require systemic therapy", "to": "Aged 1 year and older; require systemic therapy" } ] } ] }, { "key": "degarelix__firmagon", "brand": "Firmagon", "inn": "degarelix", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "f1e16b11348ca1bc", "summary": "Prostate, no biomarker required, Any line, + radiotherapy", "fields": [ { "field": "patient_eligibility", "from": "high-risk localised or locally advanced; hormone-dependent", "to": "High-risk localised or locally advanced; hormone-dependent disease" }, { "field": "review_fields", "from": [ "disease_stage" ], "to": [] } ] } ], "reworded": [ { "id": "4ed0a0a4c69f67af", "summary": "Prostate, no biomarker required, Advanced, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "hormone-dependent", "to": "Men; hormone-dependent disease" } ] }, { "id": "e4d42ede9767855c", "summary": "Prostate, no biomarker required, Neoadjuvant, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "high-risk localised or locally advanced; hormone-dependent; prior to radiotherapy", "to": "High-risk localised or locally advanced; hormone-dependent disease" } ] } ] }, { "key": "tivozanib-hydrochloride-monohydrate__fotivda", "brand": "Fotivda", "inn": "tivozanib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "45e829478cd6ea07", "summary": "RCC, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "one prior treatment with cytokine therapy; VEGFR and mTOR pathway inhibitor-naïve", "to": "One prior treatment with cytokine therapy; VEGFR and mTOR pathway inhibitor-naïve" } ] } ] }, { "key": "fruquintinib__fruzaqla", "brand": "Fruzaqla", "inn": "fruquintinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "68783b049c809977", "summary": "CRC, no biomarker required, 3rd line+, metastatic, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and progression on or intolerance to trifluridine-tipiracil or regorafenib", "to": "Available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and progressed on or intolerant to either trifluridine-tipiracil or regorafenib" } ] } ] }, { "key": "obinutuzumab__gazyvaro", "brand": "Gazyvaro", "inn": "obinutuzumab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "22f001464288f55f", "summary": "FL, no biomarker required, Maintenance, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "obinutuzumab in combination with chemotherapy achieving a response", "to": "Gazyvaro in combination with chemotherapy achieving a response" }, { "field": "patient_eligibility", "from": "achieving a response to obinutuzumab + chemotherapy", "to": null } ] }, { "id": "1e60e635127e1199", "summary": "FL, no biomarker required, Maintenance, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "obinutuzumab + bendamustine without progression; prior rituximab or a rituximab-containing regimen", "to": "Gazyvaro in combination with bendamustine without progression; did not respond or progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen" } ] } ], "reworded": [ { "id": "d159d6ff4b4f5648", "summary": "CLL, no biomarker required, 1st line, + chlorambucil", "fields": [ { "field": "patient_eligibility", "from": "comorbidities making them unsuitable for full-dose fludarabine based therapy", "to": "Comorbidities making them unsuitable for full-dose fludarabine based therapy" } ] }, { "id": "8d124eaa84782621", "summary": "FL, no biomarker required, 2nd line, + bendamustine", "fields": [ { "field": "prior_therapy", "from": "rituximab or a rituximab-containing regimen without response or with progression during or up to 6 months after treatment", "to": "Did not respond or progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen" } ] } ] }, { "key": "afatinib__giotrif", "brand": "Giotrif", "inn": "afatinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "a9c1e9e52a4a8a88", "summary": "NSCLC, activating EGFR mutation(s), Advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "No prior EGFR TKI", "to": "EGFR TKI-naïve" } ] }, { "id": "3f6efe10149958fc", "summary": "NSCLC, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "platinum-based chemotherapy", "to": "Progressed on or after platinum-based chemotherapy" } ] } ] }, { "key": "imatinib__glivec", "brand": "Glivec", "inn": "imatinib", "status": "changed", "labelChanged": false, "added": [], "removed": [ { "id": "5165ce443c964420", "summary": "MLN-TK, FIP1L1-PDGFRα rearrangement, Advanced, Monotherapy" } ], "changed": [], "reworded": [ { "id": "e612ecd69411abca", "summary": "CML, Philadelphia chromosome (bcr-abl), 1st line, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "Philadelphia chromosome (bcr-abl) positive (Ph+)", "to": "Ph+ (BCR-ABL)" }, { "field": "diagnostic_criterion", "from": "Philadelphia chromosome (bcr-abl) positive", "to": "presence of Philadelphia chromosome (bcr-abl)" }, { "field": "patient_eligibility", "from": "bone marrow transplantation is not considered as the first line of treatment", "to": "Bone marrow transplantation is not considered as the first line of treatment" } ] }, { "id": "a4496c015e2a0cb5", "summary": "CML, Philadelphia chromosome (bcr-abl), Any line, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "Ph+", "to": "Ph+ (BCR-ABL)" }, { "field": "diagnostic_criterion", "from": "Ph+", "to": "presence of Philadelphia chromosome (bcr-abl)" }, { "field": "prior_therapy", "from": "after failure of interferon-alpha therapy (if in chronic phase)", "to": "Failure of interferon-alpha therapy (for chronic phase)" } ] }, { "id": "f7979b90fa206413", "summary": "ALL, Philadelphia chromosome (bcr-abl), 1st line, + chemotherapy", "fields": [ { "field": "biomarker_detail", "from": "Philadelphia chromosome positive (Ph+)", "to": "Ph+ (BCR-ABL)" }, { "field": "diagnostic_criterion", "from": "Philadelphia chromosome positive", "to": "presence of Philadelphia chromosome (bcr-abl)" } ] }, { "id": "639183ee7fffd6ff", "summary": "ALL, Philadelphia chromosome (bcr-abl), 2nd line, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "Philadelphia chromosome positive (Ph+)", "to": "Ph+ (BCR-ABL)" }, { "field": "diagnostic_criterion", "from": "Philadelphia chromosome positive", "to": "presence of Philadelphia chromosome (bcr-abl)" }, { "field": "prior_therapy", "from": "relapsed or refractory", "to": "Relapsed or refractory disease" } ] }, { "id": "f9d14b1c7d84ff8d", "summary": "MLN-TK, PDGFR fusion, Any line, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "PDGFR gene re-arrangements", "to": "PDGFR gene rearrangement" }, { "field": "diagnostic_criterion", "from": "presence of PDGFR gene re-arrangements", "to": "presence of PDGFR gene rearrangement" } ] }, { "id": "aec31e40fe09b42f", "summary": "MLN-TK, FIP1L1-PDGFRalpha rearrangement, Advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "FIP1L1-PDGFRα rearrangement", "to": "FIP1L1-PDGFRalpha rearrangement" }, { "field": "diagnostic_criterion", "from": "presence of FIP1L1-PDGFRα rearrangement", "to": "presence of FIP1L1-PDGFRalpha rearrangement" } ] }, { "id": "90efd7fe7c4feb82", "summary": "GIST, KIT-positive, Advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "gastrointestinal stromal tumours", "to": "gastrointestinal stromal tumour" }, { "field": "biomarker_detail", "from": "Kit (CD 117) positive", "to": "Kit (CD117)-positive" }, { "field": "diagnostic_criterion", "from": "Kit (CD 117) positive", "to": "Kit (CD117) positive" } ] }, { "id": "5647ba8bf433bf59", "summary": "GIST, KIT-positive, Adjuvant, Monotherapy", "fields": [ { "field": "tumor_type", "from": "gastrointestinal stromal tumours", "to": "gastrointestinal stromal tumour" }, { "field": "biomarker_detail", "from": "Kit (CD 117) positive", "to": "Kit (CD117)-positive" }, { "field": "diagnostic_criterion", "from": "Kit (CD 117) positive", "to": "Kit (CD117) positive" }, { "field": "prior_therapy", "from": "following resection", "to": "Resection of Kit (CD117)-positive GIST" }, { "field": "patient_eligibility", "from": "significant risk of relapse", "to": "Significant risk of relapse; patients who have a low or very low risk of recurrence should not receive adjuvant treatment" } ] }, { "id": "dd473de9b5a1ede0", "summary": "Sarcoma, no biomarker required, Advanced, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "not eligible for surgery (if recurrent and/or metastatic)", "to": "Not eligible for surgery (for recurrent and/or metastatic DFSP)" } ] } ] }, { "key": "trastuzumab__herceptin", "brand": "Herceptin", "inn": "trastuzumab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "f888d58606fedd29", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, Adjuvant, early, Monotherapy", "fields": [ { "field": "tumor_type", "from": "early breast cancer", "to": "breast cancer" }, { "field": "biomarker_name", "from": "ERBB2", "to": "HER2" }, { "field": "biomarker_detail", "from": "HER2-positive (overexpression or gene amplification)", "to": "HER2 overexpression or HER2 gene amplification" }, { "field": "prior_therapy", "from": "surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable)", "to": "Following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable)" }, { "field": "review_fields", "from": [], "to": [ "treatment_phase" ] } ] } ], "reworded": [ { "id": "5c424a0c3eb3a226", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, 3rd line+, metastatic, Monotherapy", "fields": [ { "field": "biomarker_name", "from": "ERBB2", "to": "HER2" }, { "field": "biomarker_detail", "from": "HER2-positive (overexpression or gene amplification)", "to": "HER2 overexpression or HER2 gene amplification" }, { "field": "prior_therapy", "from": "at least two chemotherapy regimens for metastatic disease including at least an anthracycline and a taxane; prior hormonal therapy if hormone receptor-positive", "to": "At least two prior chemotherapy regimens for metastatic disease including an anthracycline and a taxane (unless unsuitable); failed hormonal therapy for hormone receptor-positive disease (unless unsuitable)" } ] }, { "id": "19c945147f0e0b29", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, 1st line, metastatic, + paclitaxel", "fields": [ { "field": "biomarker_name", "from": "ERBB2", "to": "HER2" }, { "field": "biomarker_detail", "from": "HER2-positive (overexpression or gene amplification)", "to": "HER2 overexpression or HER2 gene amplification" }, { "field": "patient_eligibility", "from": "anthracycline is not suitable", "to": "Anthracycline is not suitable" } ] }, { "id": "b5481fb1221d24c0", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, 1st line, metastatic, + docetaxel", "fields": [ { "field": "biomarker_name", "from": "ERBB2", "to": "HER2" }, { "field": "biomarker_detail", "from": "HER2-positive (overexpression or gene amplification)", "to": "HER2 overexpression or HER2 gene amplification" } ] }, { "id": "88a487dc28098ec6", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, HR-positive, Metastatic, + aromatase inhibitor", "fields": [ { "field": "biomarker_name", "from": "ERBB2", "to": "HER2" }, { "field": "combination", "from": "+ an aromatase inhibitor", "to": "+ aromatase inhibitor" }, { "field": "prior_therapy", "from": "no prior trastuzumab", "to": "No prior trastuzumab" }, { "field": "patient_eligibility", "from": "postmenopausal", "to": "Postmenopausal" } ] }, { "id": "b49296e16873efc6", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, Adjuvant, early, + paclitaxel or docetaxel", "fields": [ { "field": "tumor_type", "from": "early breast cancer", "to": "breast cancer" }, { "field": "biomarker_name", "from": "ERBB2", "to": "HER2" }, { "field": "biomarker_detail", "from": "HER2-positive (overexpression or gene amplification)", "to": "HER2 overexpression or HER2 gene amplification" }, { "field": "prior_therapy", "from": "adjuvant chemotherapy with doxorubicin and cyclophosphamide", "to": "Adjuvant chemotherapy with doxorubicin and cyclophosphamide" } ] }, { "id": "fe3a437678fe8519", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, Adjuvant, early, + docetaxel and carboplatin", "fields": [ { "field": "tumor_type", "from": "early breast cancer", "to": "breast cancer" }, { "field": "biomarker_name", "from": "ERBB2", "to": "HER2" }, { "field": "biomarker_detail", "from": "HER2-positive (overexpression or gene amplification)", "to": "HER2 overexpression or HER2 gene amplification" } ] }, { "id": "c8e832128978927e", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, Neoadjuvant, + neoadjuvant chemotherapy", "fields": [ { "field": "biomarker_name", "from": "ERBB2", "to": "HER2" }, { "field": "biomarker_detail", "from": "HER2-positive (overexpression or gene amplification)", "to": "HER2 overexpression or HER2 gene amplification" }, { "field": "patient_eligibility", "from": "locally advanced (including inflammatory) disease or tumours > 2 cm in diameter", "to": "Locally advanced (including inflammatory) disease or tumours > 2 cm in diameter" } ] }, { "id": "71a11172ee99c68f", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, Adjuvant, Monotherapy", "fields": [ { "field": "biomarker_name", "from": "ERBB2", "to": "HER2" }, { "field": "biomarker_detail", "from": "HER2-positive (overexpression or gene amplification)", "to": "HER2 overexpression or HER2 gene amplification" }, { "field": "prior_therapy", "from": "neoadjuvant Herceptin + chemotherapy and surgical resection", "to": "Neoadjuvant Herceptin + chemotherapy and surgical resection" }, { "field": "patient_eligibility", "from": "locally advanced (including inflammatory) disease or tumours > 2 cm in diameter", "to": "Locally advanced (including inflammatory) disease or tumours > 2 cm in diameter" } ] }, { "id": "f41c6439d0349d46", "summary": "Gastric/GEJ, HER2 IHC 3+ or IHC 2+/ISH-positive, 1st line, metastatic, + capecitabine or 5-fluorouracil, and cisplatin", "fields": [ { "field": "tumor_type", "from": "gastric or gastro-oesophageal junction adenocarcinoma", "to": "adenocarcinoma of the stomach or gastro-oesophageal junction" }, { "field": "biomarker_name", "from": "ERBB2", "to": "HER2" } ] } ] }, { "key": "serplulimab__hetronifly", "brand": "Hetronifly", "inn": "serplulimab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "06e99a1224fb159c", "summary": "SCLC, no biomarker required, 1st line, advanced, + carboplatin and etoposide", "fields": [ { "field": "tumor_type", "from": "small cell lung cancer", "to": "extensive-stage small cell lung cancer" } ] }, { "id": "92bc456436da7769", "summary": "NSCLC, EGFR/ALK/ROS1 negative, 1st line, advanced, + carboplatin and pemetrexed", "fields": [ { "field": "tumor_type", "from": "non-squamous NSCLC", "to": "non-squamous non-small cell lung carcinoma" }, { "field": "diagnostic_criterion", "from": "no EGFR, ALK or ROS1 positive mutations", "to": "absence of EGFR, ALK or ROS1 positive mutations" }, { "field": "patient_eligibility", "from": "not candidates for surgery or radiotherapy (locally advanced NSCLC)", "to": "not candidates for surgery or radiotherapy (if locally advanced)" } ] }, { "id": "565765961d6986eb", "summary": "Oesophageal, PD-L1 CPS ≥ 5, 1st line, advanced, + fluoropyrimidine- and platinum-based chemotherapy", "fields": [ { "field": "biomarker_detail", "from": "CPS ≥ 5", "to": "PD-L1 expression" } ] } ] }, { "key": "palbociclib__ibrance", "brand": "Ibrance", "inn": "palbociclib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "da38d4ba57509211", "summary": "Breast, Hormone receptor-positive, HER2-negative, Advanced, + an aromatase inhibitor", "fields": [ { "field": "diagnostic_criterion", "from": "n/a", "to": "HR-positive; HER2-negative" }, { "field": "patient_eligibility", "from": null, "to": "In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist" } ] }, { "id": "e69630cf2997dcb4", "summary": "Breast, Hormone receptor-positive, HER2-negative, 2nd line, advanced, + fulvestrant", "fields": [ { "field": "diagnostic_criterion", "from": "n/a", "to": "HR-positive; HER2-negative" }, { "field": "patient_eligibility", "from": null, "to": "Women; in pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist" } ] } ] }, { "key": "ponatinib__iclusig", "brand": "Iclusig", "inn": "ponatinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "6c169a7db7bd3037", "summary": "CML, BCR::ABL1 fusion (defines the disease), 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "dasatinib or nilotinib", "to": "Resistant to dasatinib or nilotinib, or intolerant to dasatinib or nilotinib and subsequent treatment with imatinib is not clinically appropriate" }, { "field": "patient_eligibility", "from": "chronic phase, accelerated phase, or blast phase; for intolerant patients: subsequent treatment with imatinib is not clinically appropriate", "to": null } ] }, { "id": "4f30b049ad271c69", "summary": "CML, BCR::ABL1 T315I, Any line, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "chronic phase, accelerated phase, or blast phase", "to": null } ] }, { "id": "85a28be2c34bc64b", "summary": "ALL, Philadelphia chromosome (BCR::ABL1 translocation), 2nd line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "Philadelphia chromosome positive acute lymphoblastic leukaemia", "to": "acute lymphoblastic leukaemia" }, { "field": "biomarker_detail", "from": "Philadelphia chromosome positive", "to": "Philadelphia chromosome-positive" }, { "field": "diagnostic_criterion", "from": "presence of Philadelphia chromosome (BCR::ABL1 fusion)", "to": "presence of Philadelphia chromosome (BCR::ABL1 translocation)" }, { "field": "prior_therapy", "from": "dasatinib", "to": "Resistant to dasatinib, or intolerant to dasatinib and subsequent treatment with imatinib is not clinically appropriate" }, { "field": "patient_eligibility", "from": "for intolerant patients: subsequent treatment with imatinib is not clinically appropriate", "to": null } ] }, { "id": "f1e94968e936da2c", "summary": "CML, BCR::ABL1 fusion (defines the disease), 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "dasatinib or nilotinib", "to": "Resistant to dasatinib or nilotinib, or intolerant to dasatinib or nilotinib and subsequent treatment with imatinib is not clinically appropriate" }, { "field": "patient_eligibility", "from": "for intolerant patients: subsequent treatment with imatinib is not clinically appropriate", "to": "Aged 6 years or older" } ] }, { "id": "c21a19d2149ff2ad", "summary": "CML, BCR::ABL1 T315I, Any line, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": null, "to": "Aged 6 years or older" } ] } ], "reworded": [ { "id": "c8305d46225bd232", "summary": "ALL, T315I, Philadelphia chromosome-positive, Any line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "Philadelphia chromosome positive acute lymphoblastic leukaemia", "to": "acute lymphoblastic leukaemia" }, { "field": "biomarker_detail", "from": "T315I; Philadelphia chromosome positive", "to": "T315I; Philadelphia chromosome-positive" } ] }, { "id": "e0d51767e86158a4", "summary": "ALL, Philadelphia chromosome (BCR::ABL1 translocation), 1st line, + reduced-intensity chemotherapy", "fields": [ { "field": "tumor_type", "from": "Philadelphia chromosome positive acute lymphoblastic leukaemia", "to": "acute lymphoblastic leukaemia" }, { "field": "biomarker_detail", "from": "Philadelphia chromosome positive", "to": "Philadelphia chromosome-positive" }, { "field": "diagnostic_criterion", "from": "presence of Philadelphia chromosome (BCR::ABL1 fusion)", "to": "presence of Philadelphia chromosome (BCR::ABL1 translocation)" } ] } ] }, { "key": "ibrutinib__imbruvica", "brand": "Imbruvica", "inn": "ibrutinib", "status": "changed", "labelChanged": false, "added": [], "removed": [ { "id": "f560c31bc43a546a", "summary": "MCL, no biomarker required, Maintenance, Monotherapy" } ], "changed": [ { "id": "ebb18993531f7f57", "summary": "MCL, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "relapsed or refractory", "to": null } ] } ], "reworded": [ { "id": "f608f0768145594a", "summary": "MCL, no biomarker required, 1st line, + rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (IMBRUVICA + R-CHOP) alternating with R-DHAP (or R-DHAOx) without IMBRUVICA, followed by IMBRUVICA monotherapy", "fields": [ { "field": "combination", "from": "+ rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) alternating with R-DHAP (or R-DHAOx)", "to": "+ rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (IMBRUVICA + R-CHOP) alternating with R-DHAP (or R-DHAOx) without IMBRUVICA, followed by IMBRUVICA monotherapy" }, { "field": "patient_eligibility", "from": "eligible for autologous stem cell transplantation (ASCT)", "to": "Eligible for autologous stem cell transplantation (ASCT)" } ] }, { "id": "60030237e4c6c1a7", "summary": "CLL, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least one prior therapy", "to": "At least one prior therapy" } ] }, { "id": "e02c170b767eb27a", "summary": "CLL, no biomarker required, 2nd line, + bendamustine and rituximab (BR)", "fields": [ { "field": "prior_therapy", "from": "at least one prior therapy", "to": "At least one prior therapy" } ] }, { "id": "113eff6ee2c0183c", "summary": "Waldenström, no biomarker required, 1st line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "Waldenström's macroglobulinaemia", "to": "Waldenström’s macroglobulinaemia" }, { "field": "patient_eligibility", "from": "unsuitable for chemo-immunotherapy", "to": "Unsuitable for chemo-immunotherapy" } ] }, { "id": "79aca48f38663712", "summary": "Waldenström, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "Waldenström's macroglobulinaemia", "to": "Waldenström’s macroglobulinaemia" }, { "field": "prior_therapy", "from": "at least one prior therapy", "to": "At least one prior therapy" } ] }, { "id": "15c44938d9fd2b9b", "summary": "Waldenström, no biomarker required, Any line, + rituximab", "fields": [ { "field": "tumor_type", "from": "Waldenström's macroglobulinaemia", "to": "Waldenström’s macroglobulinaemia" } ] } ] }, { "key": "tarlatamab__imdylltra", "brand": "Imdylltra", "inn": "tarlatamab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "5756c9f572e0c776", "summary": "SCLC, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "first-line treatment with platinum-based chemotherapy", "to": "Disease progression on or after first-line treatment with platinum-based chemotherapy" }, { "field": "patient_eligibility", "from": null, "to": "Who require systemic therapy" } ] } ] }, { "key": "durvalumab__imfinzi", "brand": "Imfinzi", "inn": "durvalumab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "1fae15ba58bf1380", "summary": "NSCLC, EGFR/ALK negative, Neoadjuvant, early, + platinum-based chemotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "n/a", "to": "absence of EGFR mutations or ALK rearrangements" }, { "field": "patient_eligibility", "from": "high risk of recurrence", "to": "High risk of recurrence" } ] }, { "id": "939b9ba50ad74fc6", "summary": "NSCLC, EGFR/ALK negative, Adjuvant, early, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "n/a", "to": "absence of EGFR mutations or ALK rearrangements" }, { "field": "prior_therapy", "from": "neoadjuvant durvalumab + platinum-based chemotherapy and surgical resection", "to": "Neoadjuvant durvalumab + platinum-based chemotherapy and surgical resection" }, { "field": "patient_eligibility", "from": "high risk of recurrence", "to": "High risk of recurrence" } ] }, { "id": "73969c0c36723eec", "summary": "NSCLC, TPS ≥ 1%, tumours express PD-L1 on ≥ 1% of tumour cells, Consolidation, locally advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "NSCLC", "to": "non-small cell lung cancer" }, { "field": "biomarker_detail", "from": "PD-L1 expression on ≥ 1% of tumour cells", "to": "tumours express PD-L1 on ≥ 1% of tumour cells" }, { "field": "prior_therapy", "from": "platinum-based chemoradiation therapy without progression", "to": "Platinum-based chemoradiation therapy without progression" } ] }, { "id": "87e695627356f918", "summary": "NSCLC, no sensitising EGFR mutations or ALK positive mutations, 1st line, metastatic, + tremelimumab and platinum-based chemotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "n/a", "to": "absence of sensitising EGFR mutations or ALK positive mutations" } ] }, { "id": "e9b3bd7f8db06fc7", "summary": "SCLC, no biomarker required, Consolidation, locally advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "platinum-based chemoradiation therapy without progression", "to": "Platinum-based chemoradiation therapy without progression" } ] }, { "id": "d3a1cb669e8eb481", "summary": "Endometrial, no biomarker required, 1st line, advanced, + carboplatin and paclitaxel", "fields": [ { "field": "patient_eligibility", "from": "candidates for systemic therapy", "to": "Candidates for systemic therapy" } ] }, { "id": "16b2530c03d61fa4", "summary": "Endometrial, mismatch repair deficient (dMMR), Maintenance, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "first-line durvalumab + carboplatin and paclitaxel without progression", "to": "First-line durvalumab + carboplatin and paclitaxel without progression" }, { "field": "patient_eligibility", "from": "candidates for systemic therapy", "to": "Candidates for systemic therapy" } ] }, { "id": "9d2752f7eb76127b", "summary": "Endometrial, mismatch repair proficient (pMMR), Maintenance, advanced, + olaparib", "fields": [ { "field": "prior_therapy", "from": "first-line durvalumab + carboplatin and paclitaxel without progression", "to": "First-line durvalumab + carboplatin and paclitaxel without progression" }, { "field": "patient_eligibility", "from": "candidates for systemic therapy", "to": "Candidates for systemic therapy" } ] }, { "id": "62ac3c1d9097fa06", "summary": "Urothelial, no biomarker required, Adjuvant, early, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "neoadjuvant durvalumab + gemcitabine and cisplatin and radical cystectomy", "to": "Neoadjuvant durvalumab + gemcitabine and cisplatin and radical cystectomy" } ] }, { "id": "4370d015ebe98adb", "summary": "Gastric/GEJ, no biomarker required, Adjuvant, early, + FLOT chemotherapy, followed by monotherapy", "fields": [ { "field": "prior_therapy", "from": "neoadjuvant durvalumab + FLOT chemotherapy and surgical resection", "to": "Neoadjuvant durvalumab + FLOT chemotherapy and surgical resection" } ] } ] }, { "key": "talimogene-laherparepvec__imlygic", "brand": "Imlygic", "inn": "talimogene laherparepvec", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "f24ed680af98afcc", "summary": "Melanoma, no biomarker required, Advanced, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "unresectable; regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a); no bone, brain, lung or other visceral disease", "to": "unresectable; Stage IIIB, IIIC and IVM1a; no bone, brain, lung or other visceral disease" } ] } ] }, { "key": "pomalidomide__imnovid-previously-pomalidomide-celgene-", "brand": "Imnovid (previously Pomalidomide Celgene)", "inn": "pomalidomide", "status": "added", "labelChanged": false, "added": [ { "id": "db660851e3f3fbfa", "summary": "Myeloma, no biomarker required, 2nd line, + bortezomib and dexamethasone" }, { "id": "c4540b1467612218", "summary": "Myeloma, no biomarker required, 3rd line+, + dexamethasone" } ], "removed": [], "changed": [] }, { "key": "imlunestrant__inluriyo", "brand": "Inluriyo", "inn": "imlunestrant", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "d940ff77a859802c", "summary": "Breast, ESR1 mutation, ER-positive, HER2-negative, 2nd line, advanced, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "presence of activating ESR1 mutation", "to": "presence of an activating ESR1 mutation" }, { "field": "prior_therapy", "from": "prior endocrine-based regimen", "to": "prior treatment with an endocrine based regimen" }, { "field": "patient_eligibility", "from": "In pre- or perimenopausal women, or men, should be combined with an LHRH agonist", "to": "In pre- or perimenopausal women, or men, Inluriyo should be combined with a luteinising hormone-releasing hormone (LHRH) agonist" } ] } ] }, { "key": "fedratinib__inrebic", "brand": "Inrebic", "inn": "fedratinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "f9d36b9f796d31b5", "summary": "MPN, no biomarker required, Any line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "JAK inhibitor naïve or treated with ruxolitinib", "to": "Janus Associated Kinase (JAK) inhibitor naïve or treated with ruxolitinib" } ] }, { "id": "0a23f6e91aaca13f", "summary": "MPN, no biomarker required, Any line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "JAK inhibitor naïve or treated with ruxolitinib", "to": "Janus Associated Kinase (JAK) inhibitor naïve or treated with ruxolitinib" } ] }, { "id": "79a45defc2d8ed13", "summary": "MPN, no biomarker required, Any line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "JAK inhibitor naïve or treated with ruxolitinib", "to": "Janus Associated Kinase (JAK) inhibitor naïve or treated with ruxolitinib" } ] } ] }, { "key": "gefitinib__iressa", "brand": "Iressa", "inn": "gefitinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "5de573fabdc2e1ca", "summary": "NSCLC, activating mutations of EGFR-TK, Advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "NSCLC", "to": "non-small cell lung cancer" }, { "field": "biomarker_detail", "from": "activating mutations", "to": "activating mutations of EGFR-TK" } ] } ] }, { "key": "inavolisib__itovebi", "brand": "Itovebi", "inn": "inavolisib", "status": "added", "labelChanged": false, "added": [ { "id": "bcce27fd7845c4ad", "summary": "Breast, PIK3CA mutation, ER-positive, HER2-negative, 2nd line, advanced, + palbociclib and fulvestrant" } ], "removed": [], "changed": [] }, { "key": "ruxolitinib__jakavi", "brand": "Jakavi", "inn": "ruxolitinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "3556b810a367aaae", "summary": "MPN, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "hydroxyurea", "to": "Resistant to or intolerant of hydroxyurea" }, { "field": "patient_eligibility", "from": "resistant to or intolerant of hydroxyurea", "to": null } ] } ], "reworded": [ { "id": "0c801035af783d94", "summary": "MPN, no biomarker required, Any line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "myelofibrosis (primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis)", "to": "myelofibrosis (primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis)" }, { "field": "patient_eligibility", "from": "disease-related splenomegaly or symptoms", "to": "Disease-related splenomegaly or symptoms" } ] } ] }, { "key": "pirtobrutinib__jaypirca", "brand": "Jaypirca", "inn": "pirtobrutinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "6a914720ac1ed6a5", "summary": "MCL, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor", "to": "Previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor" } ] } ] }, { "key": "dostarlimab__jemperli", "brand": "Jemperli", "inn": "dostarlimab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "e0ace567c089cb0b", "summary": "Endometrial, no biomarker required, 1st line, advanced, + carboplatin and paclitaxel", "fields": [ { "field": "patient_eligibility", "from": "candidates for systemic therapy", "to": "Candidates for systemic therapy" } ] }, { "id": "e7a5fd123705ba77", "summary": "Endometrial, MMR/MSI deficient, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior treatment with a platinum-containing regimen", "to": "Progressed on or following prior treatment with a platinum-containing regimen" } ] } ] }, { "key": "trastuzumab-emtansine__kadcyla", "brand": "Kadcyla", "inn": "trastuzumab emtansine", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "4177efc499c07635", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, Adjuvant, early, Monotherapy", "fields": [ { "field": "tumor_type", "from": "breast cancer", "to": "early breast cancer" }, { "field": "prior_therapy", "from": "neoadjuvant taxane-based and HER2-targeted therapy", "to": "Neoadjuvant taxane-based and HER2-targeted therapy" }, { "field": "patient_eligibility", "from": "residual invasive disease in the breast and/or lymph nodes", "to": "Residual invasive disease, in the breast and/or lymph nodes" } ] }, { "id": "02cc7176d1221323", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior trastuzumab and a taxane (separately or in combination); and either prior therapy for locally advanced or metastatic disease, or disease recurrence during or within six months of completing adjuvant therapy", "to": "Prior trastuzumab and a taxane, separately or in combination; and either prior therapy for locally advanced or metastatic disease, or disease recurrence during or within six months of completing adjuvant therapy" } ] } ] }, { "key": "pembrolizumab__keytruda", "brand": "Keytruda", "inn": "pembrolizumab", "status": "changed", "labelChanged": false, "added": [ { "id": "4e27ca4879d97a5a", "summary": "Endometrial, MMR/MSI deficient, Advanced, Monotherapy" } ], "removed": [ { "id": "b665735498ad8b23", "summary": "Endometrial, MMR/MSI deficient, 2nd line, advanced, Monotherapy" } ], "changed": [ { "id": "d5ea61cd1d9e1fe1", "summary": "Melanoma, no biomarker required, Advanced, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": null, "to": "Aged 12 years and older" } ] }, { "id": "b5c0956aca258c1c", "summary": "Hodgkin, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "failed ASCT, or at least two prior therapies when ASCT is not a treatment option", "to": "Failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option" }, { "field": "patient_eligibility", "from": null, "to": "Aged 3 years and older" } ] }, { "id": "dd143890f5748c52", "summary": "HNSCC, PD-L1 CPS ≥ 1, Neoadjuvant, locally advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "HNSCC", "to": "head and neck squamous cell carcinoma" }, { "field": "biomarker_detail", "from": "CPS ≥ 1", "to": "PD-L1 CPS ≥ 1" }, { "field": "review_fields", "from": [ "disease_stage" ], "to": [] } ] }, { "id": "aa9990e296bdfa0d", "summary": "HNSCC, PD-L1 CPS ≥ 1, Adjuvant, locally advanced, + radiation therapy with or without concomitant cisplatin and then as monotherapy", "fields": [ { "field": "tumor_type", "from": "HNSCC", "to": "head and neck squamous cell carcinoma" }, { "field": "biomarker_detail", "from": "CPS ≥ 1", "to": "PD-L1 CPS ≥ 1" }, { "field": "prior_therapy", "from": "neoadjuvant pembrolizumab and surgical resection", "to": "Neoadjuvant pembrolizumab and surgical resection" }, { "field": "review_fields", "from": [ "disease_stage" ], "to": [] } ] }, { "id": "92f37fddf562fc29", "summary": "TNBC, no biomarker required, Adjuvant, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "neoadjuvant pembrolizumab + chemotherapy and surgical resection", "to": "Neoadjuvant pembrolizumab + chemotherapy and surgery" }, { "field": "patient_eligibility", "from": "locally advanced, or early-stage at high risk of recurrence", "to": "Locally advanced, or early-stage at high risk of recurrence" } ] }, { "id": "6fc3430ba7cf67ad", "summary": "Endometrial, no biomarker required, Advanced, + lenvatinib", "fields": [ { "field": "line_of_therapy", "from": "2L", "to": "any" }, { "field": "prior_therapy", "from": "prior treatment with a platinum-containing therapy in any setting", "to": "Prior treatment with a platinum-containing therapy in any setting" }, { "field": "patient_eligibility", "from": "not candidates for curative surgery or radiation", "to": "Not candidates for curative surgery or radiation" } ] }, { "id": "f1c13edcf2944e1a", "summary": "Cervical, no biomarker required, 1st line, locally advanced, + chemoradiotherapy (external beam radiation therapy followed by brachytherapy)", "fields": [ { "field": "prior_therapy", "from": null, "to": "No prior definitive therapy" }, { "field": "patient_eligibility", "from": "FIGO 2014 Stage III - IVA; no prior definitive therapy", "to": "FIGO 2014 Stage III - IVA" }, { "field": "review_fields", "from": [], "to": [ "line_of_therapy" ] } ] }, { "id": "9dcb3b27afe28f8d", "summary": "Gastric/GEJ, PD-L1 CPS ≥ 1; IHC 3+ or IHC 2+/ISH-positive, HER2-positive, 1st line, advanced, + trastuzumab, fluoropyrimidine and platinum-containing chemotherapy", "fields": [ { "field": "biomarker_detail", "from": "CPS ≥ 1; HER2-positive", "to": "PD-L1 CPS ≥ 1; HER2-positive" }, { "field": "diagnostic_criterion", "from": "CPS ≥ 1; HER2: IHC 3+ or IHC 2+/ISH-positive", "to": "CPS ≥ 1; IHC 3+ or IHC 2+/ISH-positive" }, { "field": "review_fields", "from": [ "biomarker_name" ], "to": [] } ] }, { "id": "6952536aedce8f93", "summary": "Ovarian, PD-L1 CPS ≥ 1, 2nd line, + paclitaxel, with or without bevacizumab", "fields": [ { "field": "disease_stage", "from": "advanced", "to": "any" }, { "field": "biomarker_detail", "from": "CPS ≥ 1", "to": "PD-L1 CPS ≥ 1" }, { "field": "prior_therapy", "from": "one or two prior systemic treatment regimens", "to": "One or two prior systemic treatment regimens" }, { "field": "patient_eligibility", "from": "platinum-resistant", "to": "Platinum-resistant" } ] } ], "reworded": [ { "id": "e3da205c99944d83", "summary": "Melanoma, no biomarker required, Adjuvant, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "complete resection", "to": "Complete resection" }, { "field": "patient_eligibility", "from": "Stage IIB, IIC or III melanoma", "to": "Aged 12 years and older; Stage IIB, IIC or III melanoma" } ] }, { "id": "67cfeed831f591de", "summary": "NSCLC, no biomarker required, Neoadjuvant, early, + platinum-containing chemotherapy", "fields": [ { "field": "patient_eligibility", "from": "high risk of recurrence", "to": "High risk of recurrence" } ] }, { "id": "10ee6c1938bee6a2", "summary": "NSCLC, no biomarker required, Adjuvant, early, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "neoadjuvant pembrolizumab + platinum-containing chemotherapy and surgical resection", "to": "Neoadjuvant pembrolizumab + platinum-containing chemotherapy and surgical resection" }, { "field": "patient_eligibility", "from": "high risk of recurrence", "to": "High risk of recurrence" } ] }, { "id": "65b20b7b61a3924d", "summary": "NSCLC, no biomarker required, Adjuvant, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "complete resection and platinum-based chemotherapy", "to": "Complete resection and platinum-based chemotherapy" }, { "field": "patient_eligibility", "from": "high risk of recurrence", "to": "High risk of recurrence" } ] }, { "id": "0886ac4db5a33ab9", "summary": "NSCLC, PD-L1 TPS ≥ 50%, EGFR/ALK-negative, 1st line, metastatic, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "TPS ≥ 50%; EGFR and ALK wild-type", "to": "PD-L1 TPS ≥ 50%; EGFR/ALK-negative" } ] }, { "id": "31303168ce84a1a1", "summary": "NSCLC, EGFR/ALK-negative, 1st line, metastatic, + pemetrexed and platinum chemotherapy", "fields": [ { "field": "biomarker_detail", "from": "EGFR and ALK wild-type", "to": "EGFR/ALK-negative" }, { "field": "diagnostic_criterion", "from": "no EGFR or ALK positive mutations", "to": "No EGFR or ALK positive mutations" } ] }, { "id": "70f046275b479c17", "summary": "NSCLC, PD-L1 TPS ≥ 1%, 2nd line, advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "TPS ≥ 1%", "to": "PD-L1 TPS ≥ 1%" }, { "field": "prior_therapy", "from": "at least one prior chemotherapy regimen; prior targeted therapy if EGFR or ALK positive", "to": "At least one prior chemotherapy regimen; patients with EGFR or ALK positive tumour mutations should also have received targeted therapy" } ] }, { "id": "8b24fa0b02faad6d", "summary": "Urothelial, no biomarker required, Neoadjuvant, early, + enfortumab vedotin", "fields": [ { "field": "patient_eligibility", "from": "cisplatin-ineligible", "to": "Cisplatin-ineligible" } ] }, { "id": "68484b69ca7ea8fc", "summary": "Urothelial, no biomarker required, Adjuvant, early, + enfortumab vedotin", "fields": [ { "field": "prior_therapy", "from": "neoadjuvant pembrolizumab + enfortumab vedotin and radical cystectomy", "to": "Neoadjuvant pembrolizumab + enfortumab vedotin and radical cystectomy" }, { "field": "patient_eligibility", "from": "cisplatin-ineligible", "to": "Cisplatin-ineligible" } ] }, { "id": "58180c50153a926d", "summary": "Urothelial, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior platinum-containing chemotherapy", "to": "Prior platinum-containing chemotherapy" } ] }, { "id": "534311d2955e1615", "summary": "Urothelial, PD-L1 CPS ≥ 10, Advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "CPS ≥ 10", "to": "PD-L1 CPS ≥ 10" }, { "field": "patient_eligibility", "from": "cisplatin-ineligible", "to": "Cisplatin-ineligible" } ] }, { "id": "0008005937e89870", "summary": "HNSCC, PD-L1 CPS ≥ 1, 1st line, advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "HNSCC", "to": "head and neck squamous cell carcinoma" }, { "field": "biomarker_detail", "from": "CPS ≥ 1", "to": "PD-L1 CPS ≥ 1" } ] }, { "id": "95b0eeb9580b2bc8", "summary": "HNSCC, PD-L1 CPS ≥ 1, 1st line, advanced, + platinum and 5-fluorouracil (5-FU) chemotherapy", "fields": [ { "field": "tumor_type", "from": "HNSCC", "to": "head and neck squamous cell carcinoma" }, { "field": "biomarker_detail", "from": "CPS ≥ 1", "to": "PD-L1 CPS ≥ 1" } ] }, { "id": "f7b9708110dcabcd", "summary": "HNSCC, PD-L1 TPS ≥ 50%, 2nd line, advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "HNSCC", "to": "head and neck squamous cell carcinoma" }, { "field": "biomarker_detail", "from": "TPS ≥ 50%", "to": "PD-L1 TPS ≥ 50%" }, { "field": "prior_therapy", "from": "progressing on or after platinum-containing chemotherapy", "to": "Progressing on or after platinum-containing chemotherapy" } ] }, { "id": "3231a204fd7d55ce", "summary": "RCC, no biomarker required, 1st line, advanced, + axitinib", "fields": [ { "field": "tumor_type", "from": "RCC", "to": "renal cell carcinoma" } ] }, { "id": "973843ed0946ee15", "summary": "RCC, no biomarker required, 1st line, advanced, + lenvatinib", "fields": [ { "field": "tumor_type", "from": "RCC", "to": "renal cell carcinoma" } ] }, { "id": "b9dc96478b213548", "summary": "RCC, no biomarker required, Adjuvant, Monotherapy", "fields": [ { "field": "tumor_type", "from": "RCC", "to": "renal cell carcinoma" }, { "field": "prior_therapy", "from": "nephrectomy, or nephrectomy and resection of metastatic lesions", "to": "Following nephrectomy, or following nephrectomy and resection of metastatic lesions" }, { "field": "patient_eligibility", "from": "increased risk of recurrence", "to": "Increased risk of recurrence" } ] }, { "id": "5a9acb3680feff71", "summary": "CRC, MMR/MSI deficient, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "previous fluoropyrimidine-based combination therapy", "to": "Previous fluoropyrimidine-based combination therapy" } ] }, { "id": "529394122bba790b", "summary": "Gastric/GEJ, MMR/MSI deficient, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least one prior therapy", "to": "At least one prior therapy" } ] }, { "id": "61446e491c2efff6", "summary": "Small intestine, MMR/MSI deficient, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least one prior therapy", "to": "At least one prior therapy" } ] }, { "id": "d48efb4d4a104f6e", "summary": "BTC, MMR/MSI deficient, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least one prior therapy", "to": "At least one prior therapy" } ] }, { "id": "414f1a11b964eb1e", "summary": "Oesophageal, PD-L1 CPS ≥ 10, 1st line, advanced, + platinum and fluoropyrimidine-based chemotherapy", "fields": [ { "field": "biomarker_detail", "from": "CPS ≥ 10", "to": "PD-L1 CPS ≥ 10" } ] }, { "id": "fcc7a2a88f38b5a8", "summary": "TNBC, no biomarker required, Neoadjuvant, + chemotherapy", "fields": [ { "field": "patient_eligibility", "from": "locally advanced, or early-stage at high risk of recurrence", "to": "Locally advanced, or early-stage at high risk of recurrence" } ] }, { "id": "b7a5f928db130ccc", "summary": "TNBC, PD-L1 CPS ≥ 10, 1st line, advanced, + chemotherapy", "fields": [ { "field": "biomarker_detail", "from": "CPS ≥ 10", "to": "PD-L1 CPS ≥ 10" }, { "field": "prior_therapy", "from": "no prior chemotherapy for metastatic disease", "to": "No prior chemotherapy for metastatic disease" } ] }, { "id": "dc88470a36a80aa5", "summary": "Endometrial, no biomarker required, 1st line, advanced, + carboplatin and paclitaxel", "fields": [ { "field": "patient_eligibility", "from": "candidates for systemic therapy", "to": "Candidates for systemic therapy" } ] }, { "id": "42ef19dde725907d", "summary": "Cervical, PD-L1 CPS ≥ 1, Advanced, + chemotherapy with or without bevacizumab", "fields": [ { "field": "biomarker_detail", "from": "CPS ≥ 1", "to": "PD-L1 CPS ≥ 1" } ] }, { "id": "6f6a34c8f942cd71", "summary": "Gastric/GEJ, PD-L1 CPS ≥ 1, HER2-negative, 1st line, advanced, + fluoropyrimidine and platinum-containing chemotherapy", "fields": [ { "field": "biomarker_detail", "from": "CPS ≥ 1; HER2-negative", "to": "PD-L1 CPS ≥ 1; HER2-negative" } ] } ] }, { "key": "tebentafusp__kimmtrak", "brand": "Kimmtrak", "inn": "tebentafusp", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "0db4b830dc33daed", "summary": "Uveal melanoma, HLA-A*02:01-positive, Advanced, Monotherapy", "fields": [ { "field": "biomarker_name", "from": "HLA-A", "to": "HLA-A*02:01" }, { "field": "biomarker_alteration_type", "from": "mutation", "to": "overexpression" } ] } ] }, { "key": "ribociclib__kisqali", "brand": "Kisqali", "inn": "ribociclib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "59d7d23f2de77f37", "summary": "Breast, Hormone receptor-positive, HER2-negative, 1st line, advanced, + an aromatase inhibitor or fulvestrant", "fields": [ { "field": "patient_eligibility", "from": null, "to": "Women; initial endocrine-based therapy; in pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist" } ] }, { "id": "18b80aa6f113102c", "summary": "Breast, Hormone receptor-positive, HER2-negative, 2nd line, advanced, + an aromatase inhibitor or fulvestrant", "fields": [ { "field": "prior_therapy", "from": "prior endocrine therapy", "to": "Prior endocrine therapy" }, { "field": "patient_eligibility", "from": null, "to": "Women; in pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist" } ] } ], "reworded": [ { "id": "fc8ef328b9981832", "summary": "Breast, Hormone receptor-positive, HER2-negative, Adjuvant, early, + an aromatase inhibitor", "fields": [ { "field": "patient_eligibility", "from": "high risk of recurrence", "to": "High risk of recurrence; in pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist" } ] } ] }, { "key": "catumaxomab__korjuny", "brand": "Korjuny", "inn": "catumaxomab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "1028b2df1b990efa", "summary": "Tumour-agnostic, EpCAM-positive, 2nd line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "carcinoma with malignant ascites", "to": "carcinoma" }, { "field": "organ", "from": "other", "to": "tumor-agnostic" }, { "field": "biomarker_name", "from": "EPCAM", "to": "EpCAM" }, { "field": "patient_eligibility", "from": "not eligible for further systemic anticancer therapy", "to": "Malignant ascites; not eligible for further systemic anticancer therapy" }, { "field": "review_fields", "from": [ "line_of_therapy" ], "to": [ "organ", "line_of_therapy" ] } ] } ] }, { "key": "selumetinib__koselugo", "brand": "Koselugo", "inn": "selumetinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "4c6ea24b0206674e", "summary": "NF1-PN, no biomarker required, Any line, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "symptomatic; inoperable; neurofibromatosis type 1", "to": "Symptomatic; inoperable; neurofibromatosis type 1 (NF1); aged 3 years and older" } ] }, { "id": "993ea638a65dc56a", "summary": "NF1-PN, no biomarker required, Any line, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "symptomatic; inoperable; neurofibromatosis type 1; swallowing difficulties in older patients", "to": "Symptomatic; inoperable; neurofibromatosis type 1 (NF1); aged 1 year to less than 7 years, or older patients with swallowing difficulties" } ] } ] }, { "key": "adagrasib__krazati", "brand": "Krazati", "inn": "adagrasib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "a9a3fe80faa3ac3e", "summary": "NSCLC, KRAS G12C, 2nd line, advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "NSCLC", "to": "non-small cell lung cancer" }, { "field": "biomarker_detail", "from": "G12C", "to": "KRAS G12C" }, { "field": "prior_therapy", "from": "at least one prior systemic therapy", "to": "Disease progression after at least one prior systemic therapy" } ] } ] }, { "key": "tisagenlecleucel__kymriah", "brand": "Kymriah", "inn": "tisagenlecleucel", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "f66605f9458fa143", "summary": "ALL, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "refractory, in relapse post-transplant or in second or later relapse", "to": "Refractory, in relapse post-transplant or in second or later relapse" }, { "field": "patient_eligibility", "from": null, "to": "Up to and including 25 years of age" } ] } ], "reworded": [ { "id": "a47afabc6dfcc42f", "summary": "LBCL/DLBCL, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "two or more lines of systemic therapy", "to": "After two or more lines of systemic therapy" } ] }, { "id": "aa200e826f631321", "summary": "FL, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "two or more lines of systemic therapy", "to": "After two or more lines of systemic therapy" } ] } ] }, { "key": "carfilzomib__kyprolis", "brand": "Kyprolis", "inn": "carfilzomib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "6fc9fdb192970048", "summary": "Myeloma, no biomarker required, 2nd line, + daratumumab and dexamethasone", "fields": [ { "field": "prior_therapy", "from": "at least one prior therapy", "to": "At least one prior therapy" } ] }, { "id": "bf799d0d58be4fcf", "summary": "Myeloma, no biomarker required, 2nd line, + lenalidomide and dexamethasone", "fields": [ { "field": "prior_therapy", "from": "at least one prior therapy", "to": "At least one prior therapy" } ] }, { "id": "4b469c1b49f74e5b", "summary": "Myeloma, no biomarker required, 2nd line, + dexamethasone", "fields": [ { "field": "prior_therapy", "from": "at least one prior therapy", "to": "At least one prior therapy" } ] } ] }, { "key": "lazertinib__lazcluze", "brand": "Lazcluze", "inn": "lazertinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "a0ae87da5a3478d1", "summary": "NSCLC, EGFR exon 19 deletions or exon 21 L858R, 1st line, advanced, + amivantamab", "fields": [ { "field": "tumor_type", "from": "NSCLC", "to": "non-small cell lung cancer (NSCLC)" } ] } ] }, { "key": "lenvatinib__lenvima", "brand": "Lenvima", "inn": "lenvatinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "d0267aed7f8a0441", "summary": "Thyroid, no biomarker required, Advanced, Monotherapy", "fields": [ { "field": "line_of_therapy", "from": "2L", "to": "any" }, { "field": "prior_therapy", "from": "radioactive iodine (RAI)", "to": null }, { "field": "patient_eligibility", "from": "progressive; refractory to radioactive iodine (RAI)", "to": "refractory to radioactive iodine (RAI); progressive disease" }, { "field": "review_fields", "from": [ "line_of_therapy" ], "to": [] } ] }, { "id": "568cedaca955b0df", "summary": "Endometrial, no biomarker required, Advanced, + pembrolizumab", "fields": [ { "field": "line_of_therapy", "from": "2L", "to": "any" }, { "field": "prior_therapy", "from": "platinum-containing therapy in any setting", "to": "disease progression on or following prior treatment with a platinum-containing therapy in any setting" } ] } ] }, { "key": "cemiplimab__libtayo", "brand": "Libtayo", "inn": "cemiplimab", "status": "changed", "labelChanged": true, "added": [], "removed": [], "changed": [ { "id": "49cf1181bf364b49", "summary": "NSCLC, PD-L1 TPS ≥ 1%, EGFR/ALK/ROS1-negative, 1st line, advanced, + platinum-based chemotherapy", "fields": [ { "field": "disease_stage", "from": "any", "to": "advanced" }, { "field": "biomarker_detail", "from": "PD-L1 expression ≥ 1%; no EGFR, ALK or ROS1 aberrations", "to": "PD-L1 expression ≥ 1%; EGFR/ALK/ROS1-negative" }, { "field": "patient_eligibility", "from": null, "to": "Locally advanced patients must not be candidates for definitive chemoradiation" } ] } ], "reworded": [ { "id": "6d24b7fb7c08214a", "summary": "cSCC, no biomarker required, Advanced, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "not candidates for curative surgery or curative radiation", "to": "Not candidates for curative surgery or curative radiation" } ] }, { "id": "2522ad9e7006e2d8", "summary": "cSCC, no biomarker required, Adjuvant, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "surgery and radiation", "to": "Surgery and radiation" }, { "field": "patient_eligibility", "from": "high risk of recurrence", "to": "High risk of recurrence" } ] }, { "id": "304088f20dd4ba5d", "summary": "BCC, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "progressed on or intolerant to a hedgehog pathway inhibitor (HHI)", "to": "Progressed on or intolerant to a hedgehog pathway inhibitor (HHI)" } ] }, { "id": "1524dbdade55f851", "summary": "NSCLC, PD-L1 TPS ≥ 50%, EGFR/ALK/ROS1-negative, 1st line, advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "PD-L1 expression ≥ 50%; no EGFR, ALK or ROS1 aberrations", "to": "PD-L1 expression ≥ 50%; EGFR/ALK/ROS1-negative" }, { "field": "patient_eligibility", "from": "locally advanced disease: not candidates for definitive chemoradiation", "to": "Locally advanced patients must not be candidates for definitive chemoradiation" } ] }, { "id": "bd31449d2fe57c30", "summary": "Cervical, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "platinum-based chemotherapy", "to": "Platinum-based chemotherapy" } ] } ] }, { "key": "toripalimab__loqtorzi", "brand": "Loqtorzi", "inn": "toripalimab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "1e55d584bbd5a839", "summary": "NPC, no biomarker required, 1st line, advanced, + cisplatin and gemcitabine", "fields": [ { "field": "patient_eligibility", "from": null, "to": "recurrent disease not amenable to surgery or radiotherapy" } ] } ] }, { "key": "lorlatinib__lorviqua", "brand": "Lorviqua", "inn": "lorlatinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "b3bae27c8511772c", "summary": "NSCLC, ALK fusion, Advanced, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "n/a", "to": "ALK-positive" }, { "field": "prior_therapy", "from": "No prior ALK inhibitor", "to": "Previously not treated with an ALK inhibitor" } ] }, { "id": "7f06b382aa69f58c", "summary": "NSCLC, ALK fusion, 2nd line, advanced, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "n/a", "to": "ALK-positive" }, { "field": "prior_therapy", "from": "Progressed after alectinib or ceritinib as the first ALK TKI therapy, or after crizotinib and at least one other ALK TKI", "to": "Disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy, or crizotinib and at least one other ALK TKI" } ] } ] }, { "key": "sotorasib__lumykras", "brand": "Lumykras", "inn": "sotorasib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "b064708c05e07a4d", "summary": "NSCLC, KRAS G12C, 2nd line, advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "non-small cell lung cancer", "to": "NSCLC" }, { "field": "biomarker_detail", "from": "G12C", "to": "KRAS G12C" }, { "field": "diagnostic_criterion", "from": "presence of KRAS G12C mutation", "to": "KRAS G12C mutation" } ] } ] }, { "key": "lutetium-177lu-oxodotreotide__lutathera", "brand": "Lutathera", "inn": "lutetium (177Lu) oxodotreotide", "status": "added", "labelChanged": false, "added": [ { "id": "6fc503fcc501a8c0", "summary": "NET, Somatostatin receptor-positive, Advanced, Monotherapy" } ], "removed": [], "changed": [] }, { "key": "linvoseltamab__lynozyfic", "brand": "Lynozyfic", "inn": "linvoseltamab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "aa99541fab65550d", "summary": "Myeloma, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and disease progression on the last therapy", "to": "At least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and disease progression on the last therapy" } ] } ] }, { "key": "olaparib__lynparza", "brand": "Lynparza", "inn": "olaparib", "status": "changed", "labelChanged": false, "added": [ { "id": "07605f151c5cc084", "summary": "Breast, germline BRCA1/2 mutation, HER2-negative, Advanced, Monotherapy" } ], "removed": [ { "id": "1996b355b7d40e9c", "summary": "Breast, germline BRCA1/2 mutation, HER2-negative, 2nd line, advanced, Monotherapy" } ], "changed": [ { "id": "1a715aa0548bf219", "summary": "Prostate, BRCA1/2 mutation (germline and/or somatic), 2nd line, metastatic, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "germline and/or somatic BRCA1/2 mutation", "to": "BRCA1/2 mutation (germline and/or somatic)" }, { "field": "diagnostic_criterion", "from": "n/a", "to": "presence of BRCA1/2 mutation" }, { "field": "patient_eligibility", "from": null, "to": "castration-resistant" } ] }, { "id": "86571c7fd95bc980", "summary": "Prostate, no biomarker required, 1st line, metastatic, + abiraterone and prednisone or prednisolone", "fields": [ { "field": "line_of_therapy", "from": "any", "to": "1L" }, { "field": "patient_eligibility", "from": "chemotherapy is not clinically indicated", "to": "chemotherapy is not clinically indicated; castration-resistant" }, { "field": "review_fields", "from": [], "to": [ "line_of_therapy" ] } ] } ], "reworded": [ { "id": "470a94a775b6f417", "summary": "Ovarian, BRCA1/2 mutation (germline and/or somatic), Maintenance, advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "germline and/or somatic BRCA1/2 mutation", "to": "BRCA1/2 mutation (germline and/or somatic)" }, { "field": "diagnostic_criterion", "from": "n/a", "to": "presence of BRCA1/2 mutation" }, { "field": "patient_eligibility", "from": "in response (complete or partial) following completion of first-line platinum-based chemotherapy", "to": "in complete or partial response following completion of first-line platinum-based chemotherapy" } ] }, { "id": "a9b21bdc7b10f95b", "summary": "Ovarian, no biomarker required, Maintenance, advanced, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "platinum-sensitive relapsed; in response (complete or partial) to platinum-based chemotherapy", "to": "platinum-sensitive relapsed; in complete or partial response to platinum-based chemotherapy" } ] }, { "id": "70b94e37e108252c", "summary": "Ovarian, HRD-positive (BRCA1/2 mutation and/or genomic instability), Maintenance, advanced, + bevacizumab", "fields": [ { "field": "biomarker_detail", "from": "HRD positive (BRCA1/2 mutation and/or genomic instability)", "to": "HRD-positive (BRCA1/2 mutation and/or genomic instability)" }, { "field": "patient_eligibility", "from": "in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab", "to": "in complete or partial response following completion of first-line platinum-based chemotherapy in combination with bevacizumab" } ] }, { "id": "3475dc4d18a18a9f", "summary": "Breast, germline BRCA1/2 mutation, HER2-negative, Adjuvant, early, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "n/a", "to": "presence of germline BRCA1/2 mutation" }, { "field": "patient_eligibility", "from": "high risk", "to": "high risk of recurrence" } ] }, { "id": "a0cb8f1001415748", "summary": "Breast, germline BRCA1/2 mutation, HER2-negative, Adjuvant, early, + endocrine therapy", "fields": [ { "field": "diagnostic_criterion", "from": "n/a", "to": "presence of germline BRCA1/2 mutation" }, { "field": "patient_eligibility", "from": "high risk", "to": "high risk of recurrence" } ] }, { "id": "74a03de26b6caf86", "summary": "Pancreatic, germline BRCA1/2 mutation, Maintenance, metastatic, Monotherapy", "fields": [ { "field": "tumor_type", "from": "pancreatic adenocarcinoma", "to": "adenocarcinoma of the pancreas" }, { "field": "diagnostic_criterion", "from": "n/a", "to": "presence of germline BRCA1/2 mutation" } ] }, { "id": "4ac561bb1d2f226f", "summary": "Endometrial, mismatch repair proficient, Maintenance, advanced, + durvalumab", "fields": [ { "field": "biomarker_detail", "from": "pMMR (mismatch repair proficient)", "to": "pMMR" }, { "field": "diagnostic_criterion", "from": "n/a", "to": "mismatch repair proficient" } ] } ] }, { "key": "futibatinib__lytgobi", "brand": "Lytgobi", "inn": "futibatinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "7b22f24f689c81ff", "summary": "BTC, FGFR2 fusion, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least one prior line of systemic therapy", "to": "Progressed after at least one prior line of systemic therapy" } ] } ] }, { "key": "rituximab__mabthera", "brand": "MabThera", "inn": "rituximab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "b0666e577865ea2d", "summary": "FL, no biomarker required, 1st line, advanced, + chemotherapy", "fields": [ { "field": "patient_eligibility", "from": "stage III-IV", "to": null } ] }, { "id": "e5040ad4f231c6e4", "summary": "FL, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior chemotherapy", "to": "Chemoresistant or in second or subsequent relapse after chemotherapy" }, { "field": "patient_eligibility", "from": "stage III-IV; chemoresistant or in second or subsequent relapse", "to": null } ] }, { "id": "2674543bc7d1dfb0", "summary": "LBCL/DLBCL, CD20-positive, Any line, + CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone)", "fields": [ { "field": "biomarker_detail", "from": "CD20 positive", "to": "CD20-positive" }, { "field": "combination", "from": "+ CHOP chemotherapy", "to": "+ CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone)" } ] }, { "id": "98a6be93dd7bb202", "summary": "LBCL/DLBCL, CD20-positive, 1st line, advanced, + chemotherapy", "fields": [ { "field": "biomarker_detail", "from": "CD20 positive", "to": "CD20-positive" }, { "field": "patient_eligibility", "from": null, "to": "Aged 6 months to less than 18 years old" } ] }, { "id": "8b155a336028485a", "summary": "B-NHL, CD20-positive, 1st line, advanced, + chemotherapy", "fields": [ { "field": "biomarker_detail", "from": "CD20 positive", "to": "CD20-positive" }, { "field": "patient_eligibility", "from": null, "to": "Aged 6 months to less than 18 years old" } ] }, { "id": "0815fb0e427eccfa", "summary": "B-NHL, CD20-positive, 1st line, advanced, + chemotherapy", "fields": [ { "field": "biomarker_detail", "from": "CD20 positive", "to": "CD20-positive" }, { "field": "patient_eligibility", "from": null, "to": "Aged 6 months to less than 18 years old" } ] }, { "id": "b009d61ea48adc67", "summary": "CLL, no biomarker required, 2nd line, + chemotherapy", "fields": [ { "field": "prior_therapy", "from": "prior therapy", "to": "Relapsed or refractory CLL" }, { "field": "patient_eligibility", "from": "relapsed or refractory", "to": null } ] } ], "reworded": [ { "id": "77743449078d172a", "summary": "FL, no biomarker required, Maintenance, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "induction therapy", "to": "Induction therapy" }, { "field": "patient_eligibility", "from": "responding to induction therapy", "to": "Responding to induction therapy" } ] } ] }, { "key": "trametinib__mekinist", "brand": "Mekinist", "inn": "trametinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "2a2538659d47ea1a", "summary": "Melanoma, BRAF V600, Advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "BRAF V600", "to": "V600" }, { "field": "patient_eligibility", "from": null, "to": "Aged 12 years and older" } ] }, { "id": "3c07bcc1da93c164", "summary": "Melanoma, BRAF V600, Advanced, + dabrafenib", "fields": [ { "field": "biomarker_detail", "from": "BRAF V600", "to": "V600" }, { "field": "patient_eligibility", "from": null, "to": "Aged 12 years and older" } ] }, { "id": "592fc910345ff454", "summary": "Melanoma, BRAF V600, Adjuvant, locally advanced, + dabrafenib", "fields": [ { "field": "biomarker_detail", "from": "BRAF V600", "to": "V600" }, { "field": "prior_therapy", "from": "complete resection", "to": "Following complete resection" }, { "field": "patient_eligibility", "from": null, "to": "Aged 12 years and older" } ] } ], "reworded": [ { "id": "16a2ed1efa0c81c8", "summary": "NSCLC, BRAF V600, Advanced, + dabrafenib", "fields": [ { "field": "tumor_type", "from": "non-small cell lung cancer", "to": "NSCLC" }, { "field": "biomarker_detail", "from": "BRAF V600", "to": "V600" } ] }, { "id": "60abda0d5819f3e4", "summary": "Thyroid, BRAF V600E, 2nd line, advanced, + dabrafenib", "fields": [ { "field": "biomarker_detail", "from": "BRAF V600E", "to": "V600E" }, { "field": "prior_therapy", "from": "prior systemic therapy", "to": "Progressed during or after prior systemic therapy" }, { "field": "patient_eligibility", "from": "refractory to or not eligible for radioactive iodine (RAI)", "to": "Refractory to or not eligible for radioactive iodine (RAI)" } ] } ] }, { "key": "binimetinib__mektovi", "brand": "Mektovi", "inn": "binimetinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "b3e73130514382e6", "summary": "Melanoma, BRAF V600, Advanced, + encorafenib", "fields": [ { "field": "biomarker_detail", "from": "V600", "to": "BRAF V600 mutation" }, { "field": "diagnostic_criterion", "from": "BRAF V600 mutation", "to": "presence of BRAF V600 mutation" } ] }, { "id": "dbaf73993c170cbc", "summary": "NSCLC, BRAF V600E, Advanced, + encorafenib", "fields": [ { "field": "biomarker_detail", "from": "V600E", "to": "BRAF V600E mutation" }, { "field": "diagnostic_criterion", "from": "BRAF V600E mutation", "to": "presence of BRAF V600E mutation" } ] } ] }, { "key": "tafasitamab__minjuvi", "brand": "Minjuvi", "inn": "tafasitamab", "status": "changed", "labelChanged": false, "added": [], "removed": [ { "id": "2348fb1d64507248", "summary": "LBCL/DLBCL, no biomarker required, Maintenance, Monotherapy" } ], "changed": [ { "id": "9eed9048fb569fca", "summary": "FL, no biomarker required, 2nd line, + lenalidomide and rituximab", "fields": [ { "field": "tumor_type", "from": "follicular lymphoma (Grade 1-3a)", "to": "follicular lymphoma" }, { "field": "prior_therapy", "from": "at least one line of systemic therapy", "to": "after at least one line of systemic therapy" }, { "field": "patient_eligibility", "from": null, "to": "Grade 1-3a" } ] } ], "reworded": [ { "id": "589fb3c704983c7e", "summary": "LBCL/DLBCL, no biomarker required, 2nd line, + lenalidomide followed by monotherapy", "fields": [ { "field": "combination", "from": "+ lenalidomide", "to": "+ lenalidomide followed by monotherapy" } ] } ] }, { "key": "gemtuzumab-ozogamicin__mylotarg", "brand": "Mylotarg", "inn": "gemtuzumab ozogamicin", "status": "added", "labelChanged": false, "added": [ { "id": "8e406458a0524826", "summary": "AML, CD33-positive, 1st line, + daunorubicin and cytarabine" } ], "removed": [], "changed": [] }, { "key": "neratinib__nerlynx", "brand": "Nerlynx", "inn": "neratinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "d027c30198372926", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, HR-positive, Adjuvant, early, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "adjuvant trastuzumab-based therapy completed less than one year ago", "to": "Adjuvant trastuzumab-based therapy completed less than one year ago" } ] } ] }, { "key": "sorafenib__nexavar", "brand": "Nexavar", "inn": "sorafenib", "status": "changed", "labelChanged": false, "added": [], "removed": [ { "id": "f06a657d9781adbd", "summary": "RCC, no biomarker required, 1st line, advanced, Monotherapy" } ], "changed": [ { "id": "bc17a16e222c0596", "summary": "RCC, no biomarker required, Advanced, Monotherapy", "fields": [ { "field": "line_of_therapy", "from": "2L", "to": "any" }, { "field": "prior_therapy", "from": "prior interferon-alpha or interleukin-2 based therapy", "to": "Failed prior interferon-alpha or interleukin-2 based therapy, or considered unsuitable for such therapy" } ] }, { "id": "ed85b39076036bc2", "summary": "Thyroid, no biomarker required, Advanced, Monotherapy", "fields": [ { "field": "line_of_therapy", "from": "2L", "to": "any" }, { "field": "prior_therapy", "from": "radioactive iodine", "to": null }, { "field": "patient_eligibility", "from": "progressive disease; refractory to radioactive iodine", "to": "Progressive; refractory to radioactive iodine" } ] } ] }, { "key": "selinexor__nexpovio", "brand": "Nexpovio", "inn": "selinexor", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "5cfbae7aaabfbbb7", "summary": "Myeloma, no biomarker required, 3rd line+, + dexamethasone", "fields": [ { "field": "prior_therapy", "from": "at least four prior therapies including at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody", "to": "At least four prior therapies; refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, with disease progression on the last therapy" }, { "field": "patient_eligibility", "from": "refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody; disease progression on the last therapy", "to": null } ] } ], "reworded": [ { "id": "ec0c4a25b1a74cbd", "summary": "Myeloma, no biomarker required, 2nd line, + bortezomib and dexamethasone", "fields": [ { "field": "prior_therapy", "from": "at least one prior therapy", "to": "At least one prior therapy" } ] } ] }, { "key": "ixazomib__ninlaro", "brand": "Ninlaro", "inn": "ixazomib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "074864336419e6d9", "summary": "Myeloma, no biomarker required, 2nd line, + lenalidomide and dexamethasone", "fields": [ { "field": "prior_therapy", "from": "at least one prior therapy", "to": "At least one prior therapy" } ] } ] }, { "key": "darolutamide__nubeqa", "brand": "Nubeqa", "inn": "darolutamide", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "0959217a6f5f64a0", "summary": "Prostate, no biomarker required, Metastatic, + androgen deprivation therapy", "fields": [ { "field": "tumor_type", "from": "metastatic hormone-sensitive prostate cancer", "to": "metastatic hormone-sensitive prostate cancer (mHSPC)" }, { "field": "patient_eligibility", "from": null, "to": "Men" } ] }, { "id": "3c4ddb0a22eed848", "summary": "Prostate, no biomarker required, Metastatic, + docetaxel and androgen deprivation therapy", "fields": [ { "field": "tumor_type", "from": "metastatic hormone-sensitive prostate cancer", "to": "metastatic hormone-sensitive prostate cancer (mHSPC)" }, { "field": "patient_eligibility", "from": null, "to": "Men" } ] } ], "reworded": [ { "id": "ab24209cab8ae3ce", "summary": "Prostate, no biomarker required, Locally advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "non-metastatic castration-resistant prostate cancer", "to": "non-metastatic castration resistant prostate cancer (nmCRPC)" }, { "field": "patient_eligibility", "from": "high risk of developing metastatic disease", "to": "Men; high risk of developing metastatic disease" } ] } ] }, { "key": "nirogacestat__ogsiveo", "brand": "Ogsiveo", "inn": "nirogacestat", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "fa34fe8f53d624d2", "summary": "Desmoid, no biomarker required, Any line, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "progressing disease requiring systemic treatment", "to": "Progressing; requiring systemic treatment" } ] } ] }, { "key": "tovorafenib__ojemda", "brand": "Ojemda", "inn": "tovorafenib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "236e27469c17ba5b", "summary": "Glioma, BRAF fusion, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "one or more prior systemic therapies", "to": "Progressed after one or more prior systemic therapies" }, { "field": "patient_eligibility", "from": null, "to": "Aged 6 months of age and older" } ] }, { "id": "e2e1117501ca02a0", "summary": "Glioma, BRAF V600, 2nd line, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "V600", "to": "V600 mutation" }, { "field": "prior_therapy", "from": "one or more prior systemic therapies", "to": "Progressed after one or more prior systemic therapies" }, { "field": "patient_eligibility", "from": null, "to": "Aged 6 months of age and older" } ] } ] }, { "key": "momelotinib__omjjara", "brand": "Omjjara", "inn": "momelotinib", "status": "added", "labelChanged": false, "added": [ { "id": "67f3eccb9fbac90c", "summary": "MPN, no biomarker required, Any line, Monotherapy" } ], "removed": [], "changed": [] }, { "key": "nivolumab__opdivo", "brand": "Opdivo", "inn": "nivolumab", "status": "changed", "labelChanged": false, "added": [], "removed": [ { "id": "b05d69d9e86eec37", "summary": "Gastric/GEJ, no biomarker required, Adjuvant, Monotherapy" } ], "changed": [ { "id": "bf14def89e86261e", "summary": "Hodgkin, no biomarker required, 1st line, advanced, + doxorubicin, vinblastine and dacarbazine (AVD)", "fields": [ { "field": "combination", "from": "+ doxorubicin, vinblastine and dacarbazine", "to": "+ doxorubicin, vinblastine and dacarbazine (AVD)" }, { "field": "patient_eligibility", "from": null, "to": "Stage III or IV" } ] } ], "reworded": [ { "id": "145693bf332e57e9", "summary": "Melanoma, no biomarker required, Adjuvant, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "complete resection", "to": "Complete resection" } ] }, { "id": "508f2f51f58ff1da", "summary": "NSCLC, PD-L1 expression ≥ 1%, Neoadjuvant, early, + platinum-based chemotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "TPS ≥ 1%", "to": "PD-L1 expression ≥ 1%" }, { "field": "patient_eligibility", "from": "high risk of recurrence", "to": "High risk of recurrence" } ] }, { "id": "464651644edc7d5c", "summary": "NSCLC, PD-L1 expression ≥ 1%, Neoadjuvant, early, + platinum-based chemotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "TPS ≥ 1%", "to": "PD-L1 expression ≥ 1%" }, { "field": "patient_eligibility", "from": "high risk of recurrence", "to": "High risk of recurrence" } ] }, { "id": "e618da42bdeede20", "summary": "NSCLC, PD-L1 expression ≥ 1%, Adjuvant, early, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "TPS ≥ 1%", "to": "PD-L1 expression ≥ 1%" }, { "field": "prior_therapy", "from": "neoadjuvant nivolumab + platinum-based chemotherapy and surgical resection", "to": "Neoadjuvant nivolumab + platinum-based chemotherapy and surgical resection" }, { "field": "patient_eligibility", "from": "high risk of recurrence", "to": "High risk of recurrence" } ] }, { "id": "09ee90b8c2a83e25", "summary": "NSCLC, No sensitising EGFR mutation or ALK translocation, 1st line, metastatic, + ipilimumab and 2 cycles of platinum-based chemotherapy", "fields": [ { "field": "biomarker_detail", "from": "no sensitising EGFR mutation or ALK translocation", "to": "No sensitising EGFR mutation or ALK translocation" }, { "field": "diagnostic_criterion", "from": "absence of sensitising EGFR mutation or ALK translocation", "to": "No sensitising EGFR mutation or ALK translocation" } ] }, { "id": "c4081321f8564583", "summary": "NSCLC, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "chemotherapy", "to": "Prior chemotherapy" } ] }, { "id": "3bbd44a417364490", "summary": "RCC, no biomarker required, 1st line, advanced, + ipilimumab", "fields": [ { "field": "patient_eligibility", "from": "intermediate/poor-risk", "to": "Intermediate/poor-risk" } ] }, { "id": "8f2f3025b0d14442", "summary": "RCC, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior therapy", "to": "After prior therapy" } ] }, { "id": "14eaceaa5f201350", "summary": "Hodgkin, no biomarker required, 2nd line, + brentuximab vedotin", "fields": [ { "field": "prior_therapy", "from": "one prior line of therapy", "to": "After one prior line of therapy" }, { "field": "patient_eligibility", "from": "aged up to 30 years", "to": "Aged 5 up to 30 years" } ] }, { "id": "37c173b34186a07a", "summary": "Hodgkin, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "autologous stem cell transplant (ASCT) and brentuximab vedotin", "to": "After autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin" } ] }, { "id": "d4e171ea81e195f8", "summary": "HNSCC, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "platinum-based therapy", "to": "Progressing on or after platinum-based therapy" } ] }, { "id": "633ba904a0da3bb3", "summary": "Urothelial, Tumour cell PD-L1 expression ≥ 1%, Adjuvant, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "tumour cell PD-L1 expression ≥ 1%", "to": "Tumour cell PD-L1 expression ≥ 1%" }, { "field": "diagnostic_criterion", "from": "tumour cell PD-L1 expression ≥ 1%", "to": "Tumour cell PD-L1 expression ≥ 1%" }, { "field": "prior_therapy", "from": "radical resection of MIUC", "to": "Radical resection of MIUC" }, { "field": "patient_eligibility", "from": "high risk of recurrence", "to": "High risk of recurrence" } ] }, { "id": "666d6a4612af6983", "summary": "Urothelial, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "platinum-containing therapy", "to": "After failure of prior platinum-containing therapy" } ] }, { "id": "b038ce3a5ce03fcd", "summary": "CRC, Mismatch repair deficient or microsatellite instability-high, 1st line, advanced, + ipilimumab", "fields": [ { "field": "diagnostic_criterion", "from": "mismatch repair deficient or microsatellite instability-high", "to": "Mismatch repair deficient or microsatellite instability-high" } ] }, { "id": "8655b35b3ab795ba", "summary": "CRC, Mismatch repair deficient or microsatellite instability-high, 2nd line, metastatic, + ipilimumab", "fields": [ { "field": "diagnostic_criterion", "from": "mismatch repair deficient or microsatellite instability-high", "to": "Mismatch repair deficient or microsatellite instability-high" }, { "field": "prior_therapy", "from": "fluoropyrimidine-based combination chemotherapy", "to": "Prior fluoropyrimidine-based combination chemotherapy" } ] }, { "id": "87b66abdb6ae8c2b", "summary": "Oesophageal, Tumour cell PD-L1 expression ≥ 1%, 1st line, advanced, + ipilimumab", "fields": [ { "field": "biomarker_detail", "from": "tumour cell PD-L1 expression ≥ 1%", "to": "Tumour cell PD-L1 expression ≥ 1%" }, { "field": "diagnostic_criterion", "from": "tumour cell PD-L1 expression ≥ 1%", "to": "Tumour cell PD-L1 expression ≥ 1%" } ] }, { "id": "f3162cf328d22721", "summary": "Oesophageal, Tumour cell PD-L1 expression ≥ 1%, 1st line, advanced, + fluoropyrimidine- and platinum-based combination chemotherapy", "fields": [ { "field": "biomarker_detail", "from": "tumour cell PD-L1 expression ≥ 1%", "to": "Tumour cell PD-L1 expression ≥ 1%" }, { "field": "diagnostic_criterion", "from": "tumour cell PD-L1 expression ≥ 1%", "to": "Tumour cell PD-L1 expression ≥ 1%" }, { "field": "combination", "from": "+ fluoropyrimidine- and platinum-based chemotherapy", "to": "+ fluoropyrimidine- and platinum-based combination chemotherapy" } ] }, { "id": "f410c9160d1e231f", "summary": "Oesophageal, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "fluoropyrimidine- and platinum-based combination chemotherapy", "to": "Prior fluoropyrimidine- and platinum-based combination chemotherapy" } ] }, { "id": "e62adbb58c645a49", "summary": "Oesophageal, no biomarker required, Adjuvant, Monotherapy", "fields": [ { "field": "tumor_type", "from": "oesophageal cancer", "to": "oesophageal or gastro-oesophageal junction cancer" }, { "field": "prior_therapy", "from": "after neoadjuvant chemoradiotherapy", "to": "Prior neoadjuvant chemoradiotherapy" }, { "field": "patient_eligibility", "from": "residual pathologic disease following neoadjuvant chemoradiotherapy", "to": "Residual pathologic disease" } ] }, { "id": "2881332c38302050", "summary": "Gastric/GEJ, PD-L1 CPS ≥ 5, HER2-negative, 1st line, advanced, + fluoropyrimidine- and platinum-based combination chemotherapy", "fields": [ { "field": "combination", "from": "+ fluoropyrimidine- and platinum-based chemotherapy", "to": "+ fluoropyrimidine- and platinum-based combination chemotherapy" } ] }, { "id": "084bce67f3f84e3a", "summary": "Oesophageal, PD-L1 CPS ≥ 5, HER2-negative, 1st line, advanced, + fluoropyrimidine- and platinum-based combination chemotherapy", "fields": [ { "field": "combination", "from": "+ fluoropyrimidine- and platinum-based chemotherapy", "to": "+ fluoropyrimidine- and platinum-based combination chemotherapy" } ] } ] }, { "key": "relatlimab-nivolumab__opdualag", "brand": "Opdualag", "inn": "relatlimab;nivolumab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "f1594f11e83dd972", "summary": "Melanoma, PD-L1 TPS < 1%, 1st line, advanced, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "tumour cell PD-L1 expression < 1%", "to": "TPS < 1%" }, { "field": "patient_eligibility", "from": null, "to": "aged 12 years and older" } ] } ] }, { "key": "odronextamab__ordspono", "brand": "Ordspono", "inn": "odronextamab", "status": "added", "labelChanged": false, "added": [ { "id": "e4bfde777eb39920", "summary": "FL, no biomarker required, 3rd line+, Monotherapy" }, { "id": "f7cb876925f8a799", "summary": "LBCL/DLBCL, no biomarker required, 3rd line+, Monotherapy" } ], "removed": [], "changed": [] }, { "key": "relugolix__orgovyx", "brand": "Orgovyx", "inn": "relugolix", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "a55f001ee241e96b", "summary": "Prostate, no biomarker required, Advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "hormone-sensitive prostate cancer", "to": "prostate cancer" }, { "field": "patient_eligibility", "from": null, "to": "hormone-sensitive" } ] } ] }, { "key": "elacestrant__orserdu", "brand": "Orserdu", "inn": "elacestrant", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "e83d1e8518755976", "summary": "Breast, ESR1 mutation, ER-positive, HER2-negative, 2nd line, advanced, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "presence of an activating ESR1 mutation", "to": "presence of activating ESR1 mutation" }, { "field": "prior_therapy", "from": "at least one line of endocrine therapy including a CDK 4/6 inhibitor", "to": "At least one line of endocrine therapy including a CDK 4/6 inhibitor" }, { "field": "patient_eligibility", "from": "postmenopausal women, or men", "to": "Postmenopausal women, and men" } ] } ] }, { "key": "enfortumab-vedotin__padcev", "brand": "Padcev", "inn": "enfortumab vedotin", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "0487920a769c0cf2", "summary": "Urothelial, no biomarker required, Adjuvant, early, + pembrolizumab", "fields": [ { "field": "prior_therapy", "from": "neoadjuvant enfortumab vedotin in combination with pembrolizumab and radical cystectomy", "to": "Neoadjuvant enfortumab vedotin + pembrolizumab and radical cystectomy" } ] }, { "id": "19a960bce41a422a", "summary": "Urothelial, no biomarker required, 1st line, advanced, + pembrolizumab", "fields": [ { "field": "patient_eligibility", "from": "eligible for platinum-containing chemotherapy", "to": "Eligible for platinum-containing chemotherapy" } ] }, { "id": "db199a045997be82", "summary": "Urothelial, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "platinum-containing chemotherapy and a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor", "to": "Previously received a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor" } ] } ] }, { "key": "peginterferon-alfa-2a__pegasys", "brand": "Pegasys", "inn": "peginterferon alfa-2a", "status": "added", "labelChanged": false, "added": [ { "id": "9a2549d9a587fcf0", "summary": "MPN, no biomarker required, Any line, Monotherapy" }, { "id": "ae9b3e1a8d709673", "summary": "MPN, no biomarker required, Any line, Monotherapy" } ], "removed": [], "changed": [] }, { "key": "pertuzumab__perjeta", "brand": "Perjeta", "inn": "pertuzumab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "1411db01d135ff9f", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, 1st line, advanced, + trastuzumab and docetaxel", "fields": [ { "field": "combination", "from": "+ docetaxel and trastuzumab", "to": "+ trastuzumab and docetaxel" } ] } ] }, { "key": "pertuzumab-trastuzumab__phesgo", "brand": "Phesgo", "inn": "pertuzumab;trastuzumab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "e294c1ea3d4f0e4b", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, Neoadjuvant, + chemotherapy", "fields": [ { "field": "patient_eligibility", "from": "locally advanced, inflammatory, or early stage; high risk of recurrence", "to": "Locally advanced, inflammatory, or early stage; high risk of recurrence" } ] }, { "id": "739b21ce6c81a57c", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, Adjuvant, early, + chemotherapy", "fields": [ { "field": "patient_eligibility", "from": "high risk of recurrence", "to": "High risk of recurrence" } ] } ] }, { "key": "alpelisib__piqray", "brand": "Piqray", "inn": "alpelisib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "a0a8e4ce6b58ac1c", "summary": "Breast, PIK3CA mutation, HR-positive, HER2-negative, 2nd line, advanced, + fulvestrant", "fields": [ { "field": "diagnostic_criterion", "from": "n/a", "to": "PIK3CA mutation" }, { "field": "prior_therapy", "from": "endocrine-based regimen", "to": "Following an endocrine-based regimen" }, { "field": "patient_eligibility", "from": "postmenopausal women, or men", "to": "Postmenopausal women, and men" } ] } ] }, { "key": "lutetium-177lu-vipivotide-tetraxetan__pluvicto", "brand": "Pluvicto", "inn": "lutetium (177Lu) vipivotide tetraxetan", "status": "added", "labelChanged": false, "added": [ { "id": "d90a43cdf00c6fec", "summary": "Prostate, PSMA-positive, 3rd line+, metastatic, + androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition" } ], "removed": [], "changed": [] }, { "key": "polatuzumab-vedotin__polivy", "brand": "Polivy", "inn": "polatuzumab vedotin", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "1d257c4aff72bcad", "summary": "LBCL/DLBCL, no biomarker required, 1st line, + rituximab, cyclophosphamide, doxorubicin, and prednisone", "fields": [ { "field": "combination", "from": "+ rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP)", "to": "+ rituximab, cyclophosphamide, doxorubicin, and prednisone" } ] }, { "id": "b5ffa05721fc8c7d", "summary": "LBCL/DLBCL, no biomarker required, 2nd line, + bendamustine and rituximab", "fields": [ { "field": "patient_eligibility", "from": "not candidates for haematopoietic stem cell transplant", "to": "Not candidates for haematopoietic stem cell transplant" } ] } ] }, { "key": "dinutuximab-beta__qarziba-previously-dinutuximab-beta-eusa-and-dinutuximab-beta-apeiron-", "brand": "Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)", "inn": "dinutuximab beta", "status": "changed", "labelChanged": false, "added": [ { "id": "f33ebf40670888c0", "summary": "Neuroblastoma, no biomarker required, 1st line, + interleukin-2 (IL-2)" } ], "removed": [], "changed": [ { "id": "909a508d74eaefba", "summary": "Neuroblastoma, no biomarker required, 1st line, Monotherapy", "fields": [ { "field": "combination", "from": "monotherapy or + interleukin-2 (IL-2)", "to": "monotherapy" }, { "field": "prior_therapy", "from": "induction chemotherapy with at least a partial response, followed by myeloablative therapy and stem cell transplantation", "to": "Induction chemotherapy with at least a partial response, followed by myeloablative therapy and stem cell transplantation" }, { "field": "patient_eligibility", "from": "high-risk; combined with IL-2 if complete response was not achieved after first-line therapy", "to": "High-risk neuroblastoma; aged 12 months and above; achieved at least a partial response to induction chemotherapy; in patients who have not achieved a complete response after first line therapy, Qarziba should be combined with interleukin-2 (IL-2)" }, { "field": "review_fields", "from": [ "line_of_therapy", "combination" ], "to": [] } ] } ], "reworded": [ { "id": "fc677fc942256a8a", "summary": "Neuroblastoma, no biomarker required, 2nd line, advanced, + interleukin-2 (IL-2)", "fields": [ { "field": "prior_therapy", "from": "prior therapy for neuroblastoma", "to": "Prior systemic therapy (history of relapsed or refractory neuroblastoma)" }, { "field": "patient_eligibility", "from": "history of relapsed or refractory disease; with or without residual disease; actively progressing disease must be stabilised prior to treatment", "to": "Aged 12 months and above; with or without residual disease; actively progressing disease should be stabilised by other suitable measures prior to treatment" } ] } ] }, { "key": "ripretinib__qinlock", "brand": "Qinlock", "inn": "ripretinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "501fe1902a3365f6", "summary": "GIST, no biomarker required, 3rd line+, advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "gastrointestinal stromal tumour", "to": "gastrointestinal stromal tumour (GIST)" }, { "field": "prior_therapy", "from": "three or more prior kinase inhibitors, including imatinib", "to": "Three or more prior kinase inhibitors, including imatinib" } ] } ] }, { "key": "selpercatinib__retsevmo", "brand": "Retsevmo", "inn": "selpercatinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "89469527f89e91e1", "summary": "Thyroid, RET mutation, Advanced, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "presence of RET mutation", "to": "RET mutation" }, { "field": "patient_eligibility", "from": null, "to": "Aged 2 years and older" } ] }, { "id": "8bba369c24d538e3", "summary": "Tumour-agnostic, RET fusion, Advanced, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "presence of RET fusion", "to": "RET fusion-positive" }, { "field": "prior_therapy", "from": "treatment options not targeting RET provide limited clinical benefit or have been exhausted", "to": "Treatment options not targeting RET provide limited clinical benefit, or have been exhausted" }, { "field": "patient_eligibility", "from": null, "to": "Aged 2 years and older" } ] } ], "reworded": [ { "id": "edb243f48af17712", "summary": "NSCLC, RET fusion, Advanced, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "presence of RET fusion", "to": "RET fusion-positive" }, { "field": "prior_therapy", "from": "No prior RET inhibitor", "to": "Not previously treated with a RET inhibitor" } ] }, { "id": "5e8c86061c9c8fea", "summary": "Thyroid, RET fusion, Advanced, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "presence of RET fusion", "to": "RET fusion-positive" }, { "field": "patient_eligibility", "from": "radioactive iodine-refractory (if radioactive iodine is appropriate)", "to": "Radioactive iodine-refractory (if radioactive iodine is appropriate); aged 2 years and older" } ] } ] }, { "key": "lenalidomide__revlimid", "brand": "Revlimid", "inn": "lenalidomide", "status": "added", "labelChanged": false, "added": [ { "id": "1285bef661380092", "summary": "Myeloma, no biomarker required, Maintenance, Monotherapy" }, { "id": "2ea90f3a401fe1c4", "summary": "Myeloma, no biomarker required, 1st line, + dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone" }, { "id": "be40f318d1624455", "summary": "Myeloma, no biomarker required, 2nd line, + dexamethasone" }, { "id": "64cc9ee8196b3937", "summary": "MDS, isolated deletion 5q cytogenetic abnormality, Any line, Monotherapy" }, { "id": "ce3635d83956180d", "summary": "MCL, no biomarker required, 2nd line, Monotherapy" }, { "id": "d324653731cf37b2", "summary": "FL, no biomarker required, 2nd line, + rituximab" } ], "removed": [], "changed": [] }, { "key": "vimseltinib__romvimza", "brand": "Romvimza", "inn": "vimseltinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "1325110e16c9c648", "summary": "TGCT, no biomarker required, Any line, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "symptomatic; associated with clinically relevant physical function deterioration; surgical options have been exhausted or would induce unacceptable morbidity or disability", "to": "symptomatic; clinically relevant physical function deterioration; surgical options have been exhausted or would induce unacceptable morbidity or disability" } ] } ] }, { "key": "entrectinib__rozlytrek", "brand": "Rozlytrek", "inn": "entrectinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "8d9e0d90b69f3f5f", "summary": "Tumour-agnostic, NTRK fusion, Any line, Monotherapy", "fields": [ { "field": "disease_stage", "from": "advanced", "to": "any" }, { "field": "patient_eligibility", "from": "surgical resection is likely to result in severe morbidity; no satisfactory treatment options", "to": "Aged older than 1 month; locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options" } ] } ] }, { "key": "rucaparib__rubraca", "brand": "Rubraca", "inn": "rucaparib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "2f371941f78a3f16", "summary": "Ovarian, no biomarker required, Maintenance, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "first-line platinum-based chemotherapy", "to": "First-line platinum-based chemotherapy" }, { "field": "patient_eligibility", "from": "in response (complete or partial) following completion of first-line platinum-based chemotherapy", "to": "In complete or partial response following completion of first-line platinum-based chemotherapy" } ] }, { "id": "2d1060c239ae2f5f", "summary": "Ovarian, no biomarker required, Maintenance, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "platinum-based chemotherapy", "to": "Platinum-based chemotherapy" }, { "field": "patient_eligibility", "from": "platinum-sensitive; in response (complete or partial) to platinum-based chemotherapy", "to": "Platinum-sensitive; in complete or partial response to platinum-based chemotherapy" } ] } ] }, { "key": "ruxolitinib-hemifumarate__ruxolitinib-viatris", "brand": "Ruxolitinib Viatris", "inn": "ruxolitinib", "status": "changed", "labelChanged": false, "added": [], "removed": [ { "id": "9fb8dfe7421d72ba", "summary": "MPN, no biomarker required, Any line, Monotherapy" }, { "id": "8abceef271c2e924", "summary": "MPN, no biomarker required, Any line, Monotherapy" } ], "changed": [ { "id": "41cbabbf65209980", "summary": "MPN, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "hydroxyurea", "to": "Resistant to or intolerant of hydroxyurea" }, { "field": "patient_eligibility", "from": "resistant to or intolerant of hydroxyurea", "to": null } ] } ], "reworded": [ { "id": "4659fd70439a3ac4", "summary": "MPN, no biomarker required, Any line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "primary myelofibrosis", "to": "primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis" }, { "field": "patient_eligibility", "from": "disease-related splenomegaly or symptoms", "to": "Disease-related splenomegaly or symptoms" } ] } ] }, { "key": "amivantamab__rybrevant", "brand": "Rybrevant", "inn": "amivantamab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "68c83ac42b92a329", "summary": "NSCLC, EGFR exon 19 deletions or exon 21 L858R, 1st line, advanced, + lazertinib", "fields": [ { "field": "diagnostic_criterion", "from": "presence of EGFR Exon 19 deletion or Exon 21 L858R substitution mutation", "to": "Exon 19 deletions or Exon 21 L858R substitution mutations" } ] }, { "id": "e61a829de4c4dbc7", "summary": "NSCLC, EGFR exon 19 deletions or exon 21 L858R, 2nd line, advanced, + carboplatin and pemetrexed", "fields": [ { "field": "diagnostic_criterion", "from": "presence of EGFR Exon 19 deletion or Exon 21 L858R substitution mutation", "to": "Exon 19 deletions or Exon 21 L858R substitution mutations" }, { "field": "prior_therapy", "from": "prior therapy including an EGFR tyrosine kinase inhibitor (TKI)", "to": "After failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI)" } ] }, { "id": "64dec14e5b5ef210", "summary": "NSCLC, EGFR exon 20 insertion, 1st line, advanced, + carboplatin and pemetrexed", "fields": [ { "field": "diagnostic_criterion", "from": "presence of activating EGFR Exon 20 insertion mutation", "to": "activating EGFR Exon 20 insertion mutations" } ] }, { "id": "8c2806b1492bd614", "summary": "NSCLC, EGFR exon 20 insertion, 2nd line, advanced, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "presence of activating EGFR Exon 20 insertion mutation", "to": "activating EGFR Exon 20 insertion mutations" }, { "field": "prior_therapy", "from": "platinum-based therapy", "to": "After failure of platinum-based therapy" } ] } ] }, { "key": "midostaurin__rydapt", "brand": "Rydapt", "inn": "midostaurin", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "4ea6c98af2562dbc", "summary": "AML, FLT3 mutation, Induction, + standard daunorubicin and cytarabine", "fields": [ { "field": "combination", "from": "+ standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy", "to": "+ standard daunorubicin and cytarabine" }, { "field": "review_fields", "from": [ "combination" ], "to": [] } ] }, { "id": "c903fad7b5f1e402", "summary": "AML, FLT3 mutation, Consolidation, + high-dose cytarabine", "fields": [ { "field": "tumor_type", "from": "acute myeloid leukaemia (AML)", "to": "acute myeloid leukaemia" }, { "field": "diagnostic_criterion", "from": "presence of FLT3 mutation", "to": "FLT3 mutation-positive" }, { "field": "prior_therapy", "from": "midostaurin + standard daunorubicin and cytarabine induction", "to": "standard daunorubicin and cytarabine induction chemotherapy" } ] }, { "id": "35f2af4d7f890ce9", "summary": "AML, FLT3 mutation, Maintenance, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "midostaurin + standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation; complete response", "to": "standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy" } ] } ], "reworded": [ { "id": "b98e209a378038ce", "summary": "Mastocytosis, no biomarker required, Any line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "systemic mastocytosis with associated haematological neoplasm", "to": "aggressive systemic mastocytosis" } ] }, { "id": "4e259b687d0c7e34", "summary": "Mastocytosis, no biomarker required, Any line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "aggressive systemic mastocytosis", "to": "systemic mastocytosis with associated haematological neoplasm" } ] } ] }, { "key": "imetelstat__rytelo", "brand": "Rytelo", "inn": "imetelstat", "status": "changed", "labelChanged": false, "added": [], "removed": [ { "id": "6aaa7200bd7c7302", "summary": "MDS, absence of isolated deletion 5q cytogenetic abnormality, non-del(5q), 2nd line, Monotherapy" } ], "changed": [ { "id": "22d2c4d95beca8a9", "summary": "MDS, without an isolated deletion 5q cytogenetic (non-del 5q) abnormality, Any line, Monotherapy", "fields": [ { "field": "line_of_therapy", "from": "1L", "to": "any" }, { "field": "biomarker_detail", "from": "non-del(5q)", "to": "without an isolated deletion 5q cytogenetic (non-del 5q) abnormality" }, { "field": "diagnostic_criterion", "from": "absence of isolated deletion 5q cytogenetic abnormality", "to": "absence of isolated deletion 5q" }, { "field": "patient_eligibility", "from": "transfusion-dependent anaemia; very low, low or intermediate risk; ineligible for erythropoietin-based therapy", "to": "transfusion-dependent anaemia; very low, low or intermediate risk MDS; unsatisfactory response to or ineligible for erythropoietin-based therapy" } ] } ] }, { "key": "isatuximab__sarclisa", "brand": "Sarclisa", "inn": "isatuximab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "c54497ed6d5290a4", "summary": "Myeloma, no biomarker required, 3rd line+, + pomalidomide and dexamethasone", "fields": [ { "field": "prior_therapy", "from": "at least two prior therapies including lenalidomide and a proteasome inhibitor with disease progression on the last therapy", "to": "at least two prior therapies including lenalidomide and a proteasome inhibitor, with disease progression on the last therapy" }, { "field": "patient_eligibility", "from": "relapsed and refractory", "to": null } ] } ], "reworded": [ { "id": "1027014941ab6434", "summary": "Myeloma, no biomarker required, 1st line, + bortezomib, lenalidomide, and dexamethasone", "fields": [ { "field": "patient_eligibility", "from": "ineligible for autologous stem cell transplant", "to": "transplant-ineligible" } ] }, { "id": "47a765468a13f6e7", "summary": "Myeloma, no biomarker required, Induction, + bortezomib, lenalidomide, and dexamethasone", "fields": [ { "field": "patient_eligibility", "from": "eligible for autologous stem cell transplant", "to": "transplant-eligible" } ] } ] }, { "key": "asciminib__scemblix", "brand": "Scemblix", "inn": "asciminib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "85bbeb21feca3a65", "summary": "CML, T315I, Philadelphia chromosome-positive, Any line, Monotherapy", "fields": [ { "field": "biomarker_name", "from": "BCR-ABL1", "to": "ABL1" }, { "field": "prior_therapy", "from": "resistant to or intolerant to ponatinib (unless ineligible)", "to": "Resistant to, intolerant to or ineligible for ponatinib" }, { "field": "patient_eligibility", "from": "ineligible for ponatinib (if not resistant or intolerant)", "to": null } ] } ], "reworded": [ { "id": "53d4336706482a9a", "summary": "CML, Philadelphia chromosome or BCR-ABL1 fusion, Any line, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "Philadelphia chromosome-positive", "to": "Philadelphia chromosome-positive (Ph+)" }, { "field": "diagnostic_criterion", "from": "presence of Philadelphia chromosome / BCR-ABL1 translocation", "to": "presence of Philadelphia chromosome or BCR-ABL1 fusion" } ] } ] }, { "key": "trametinib__spexotras", "brand": "Spexotras", "inn": "trametinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "a7260396525685f4", "summary": "Glioma, BRAF V600E, Any line, + dabrafenib", "fields": [ { "field": "line_of_therapy", "from": "2L", "to": "any" }, { "field": "biomarker_detail", "from": "V600E", "to": "BRAF V600E" }, { "field": "prior_therapy", "from": "at least one prior radiation and/or chemotherapy treatment", "to": "At least one prior radiation and/or chemotherapy treatment" }, { "field": "patient_eligibility", "from": null, "to": "Aged 1 year and older" }, { "field": "review_fields", "from": [ "line_of_therapy" ], "to": [] } ] } ], "reworded": [ { "id": "7bff74550c696b1a", "summary": "Glioma, BRAF V600E, Any line, + dabrafenib", "fields": [ { "field": "biomarker_detail", "from": "V600E", "to": "BRAF V600E" }, { "field": "patient_eligibility", "from": "require systemic therapy", "to": "Aged 1 year and older; require systemic therapy" } ] } ] }, { "key": "dasatinib-anhydrous-__sprycel", "brand": "Sprycel", "inn": "dasatinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "5c8504e5514d8d18", "summary": "CML, BCR::ABL1 fusion, 1st line, Monotherapy", "fields": [ { "field": "biomarker_name", "from": "BCR-ABL1", "to": "BCR::ABL1" }, { "field": "biomarker_detail", "from": "Philadelphia chromosome positive (Ph+)", "to": "Ph+" }, { "field": "patient_eligibility", "from": null, "to": "Chronic phase" } ] }, { "id": "1a47c5b708cdf2f3", "summary": "CML, BCR::ABL1 fusion, 2nd line, Monotherapy", "fields": [ { "field": "biomarker_name", "from": "BCR-ABL1", "to": "BCR::ABL1" }, { "field": "prior_therapy", "from": "prior therapy including imatinib", "to": "Resistance or intolerance to prior therapy including imatinib" }, { "field": "patient_eligibility", "from": null, "to": "Chronic, accelerated or blast phase" } ] }, { "id": "039c8ac173d8c1f7", "summary": "CML, BCR::ABL1 fusion, 2nd line, Monotherapy", "fields": [ { "field": "biomarker_name", "from": "BCR-ABL1", "to": "BCR::ABL1" }, { "field": "prior_therapy", "from": "prior therapy", "to": "Resistance or intolerance to prior therapy" }, { "field": "patient_eligibility", "from": null, "to": "Lymphoid blast phase" } ] }, { "id": "5c91b22e2abc2945", "summary": "CML, BCR::ABL1 fusion, 1st line, Monotherapy", "fields": [ { "field": "biomarker_name", "from": "BCR-ABL1", "to": "BCR::ABL1" }, { "field": "patient_eligibility", "from": null, "to": "Chronic phase" } ] }, { "id": "988fb4b4597ac8f3", "summary": "CML, BCR::ABL1 fusion, 2nd line, Monotherapy", "fields": [ { "field": "biomarker_name", "from": "BCR-ABL1", "to": "BCR::ABL1" }, { "field": "prior_therapy", "from": "prior therapy including imatinib", "to": "Resistance or intolerance to prior therapy including imatinib" }, { "field": "patient_eligibility", "from": null, "to": "Chronic phase" } ] } ], "reworded": [ { "id": "a75529ece893f55e", "summary": "ALL, BCR::ABL1 fusion, 2nd line, Monotherapy", "fields": [ { "field": "biomarker_name", "from": "BCR-ABL1", "to": "BCR::ABL1" }, { "field": "prior_therapy", "from": "prior therapy", "to": "Resistance or intolerance to prior therapy" } ] }, { "id": "889494588713f5f5", "summary": "ALL, BCR::ABL1 fusion, 1st line, + chemotherapy", "fields": [ { "field": "biomarker_name", "from": "BCR-ABL1", "to": "BCR::ABL1" } ] } ] }, { "key": "regorafenib__stivarga", "brand": "Stivarga", "inn": "regorafenib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "065cea8d797fb7da", "summary": "CRC, no biomarker required, Metastatic, Monotherapy", "fields": [ { "field": "line_of_therapy", "from": "3L+", "to": "any" }, { "field": "prior_therapy", "from": "fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy", "to": "previously treated with, or are not considered candidates for, available therapies (including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy)" }, { "field": "patient_eligibility", "from": "not considered candidates for available therapies", "to": null }, { "field": "review_fields", "from": [ "line_of_therapy" ], "to": [] } ] }, { "id": "440bf9476bfb506a", "summary": "GIST, no biomarker required, 3rd line+, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior treatment with imatinib and sunitinib", "to": "progressed on or are intolerant to prior treatment with imatinib and sunitinib" }, { "field": "patient_eligibility", "from": "intolerant to prior treatment with imatinib and sunitinib", "to": null } ] } ] }, { "key": "sunitinib__sutent", "brand": "Sutent", "inn": "sunitinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "d81912a1cbac8df0", "summary": "GIST, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "malignant gastrointestinal stromal tumour (GIST)", "to": "gastrointestinal stromal tumour (GIST)" }, { "field": "prior_therapy", "from": "imatinib", "to": "imatinib treatment (failure due to resistance or intolerance)" } ] }, { "id": "9a9a5a83abad2f01", "summary": "NET, no biomarker required, Advanced, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "with disease progression", "to": "disease progression" } ] } ] }, { "key": "capmatinib__tabrecta", "brand": "Tabrecta", "inn": "capmatinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "41f1fa6b9d948b8f", "summary": "NSCLC, alterations leading to METex14 skipping, 2nd line, advanced, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "presence of alterations leading to METex14 skipping", "to": "alterations leading to METex14 skipping" } ] } ] }, { "key": "dabrafenib__tafinlar", "brand": "Tafinlar", "inn": "dabrafenib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "4af78ed1a463ec4d", "summary": "Melanoma, BRAF V600, Advanced, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "presence of BRAF V600 mutation", "to": "BRAF V600 mutation" }, { "field": "patient_eligibility", "from": null, "to": "Aged 12 years and older" } ] }, { "id": "84215500abc20b1b", "summary": "Melanoma, BRAF V600, Advanced, + trametinib", "fields": [ { "field": "diagnostic_criterion", "from": "presence of BRAF V600 mutation", "to": "BRAF V600 mutation" }, { "field": "patient_eligibility", "from": null, "to": "Aged 12 years and older" } ] }, { "id": "f576c88855c4d721", "summary": "Melanoma, BRAF V600, Adjuvant, locally advanced, + trametinib", "fields": [ { "field": "diagnostic_criterion", "from": "presence of BRAF V600 mutation", "to": "BRAF V600 mutation" }, { "field": "prior_therapy", "from": "complete resection", "to": "Complete resection" }, { "field": "patient_eligibility", "from": null, "to": "Aged 12 years and older" } ] } ], "reworded": [ { "id": "e39aff22f2478cf0", "summary": "NSCLC, BRAF V600, Advanced, + trametinib", "fields": [ { "field": "tumor_type", "from": "non-small cell lung cancer", "to": "NSCLC" }, { "field": "diagnostic_criterion", "from": "presence of BRAF V600 mutation", "to": "BRAF V600 mutation" } ] }, { "id": "253a82648c6482cf", "summary": "Thyroid, BRAF V600E, 2nd line, advanced, + trametinib", "fields": [ { "field": "diagnostic_criterion", "from": "presence of BRAF V600E mutation", "to": "BRAF V600E mutation" }, { "field": "prior_therapy", "from": "prior systemic therapy", "to": "Prior systemic therapy" }, { "field": "patient_eligibility", "from": "refractory to or not eligible for radioactive iodine (RAI)", "to": "Refractory to or not eligible for radioactive iodine (RAI)" } ] } ] }, { "key": "osimertinib__tagrisso", "brand": "Tagrisso", "inn": "osimertinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "6772c64cec6d4d1e", "summary": "NSCLC, EGFR exon 19 deletions or exon 21 (L858R), Adjuvant, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "complete tumour resection", "to": "Complete tumour resection" } ] }, { "id": "84c9f1eceebea66c", "summary": "NSCLC, EGFR exon 19 deletions or exon 21 (L858R), Consolidation, locally advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "platinum-based chemoradiation therapy", "to": "Platinum-based chemoradiation therapy without disease progression" }, { "field": "patient_eligibility", "from": "unresectable; disease has not progressed during or following platinum-based chemoradiation therapy", "to": "Unresectable; disease has not progressed during or following platinum-based chemoradiation therapy" } ] }, { "id": "2c4089169d98021b", "summary": "NSCLC, EGFR mutation, 1st line, advanced, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "activating EGFR mutation", "to": "presence of activating EGFR mutation" } ] }, { "id": "4aed1b98cb4921af", "summary": "NSCLC, EGFR T790M, Advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "T790M mutation-positive", "to": "T790M" }, { "field": "diagnostic_criterion", "from": "EGFR T790M mutation", "to": "presence of EGFR T790M mutation" } ] } ] }, { "key": "talquetamab__talvey", "brand": "Talvey", "inn": "talquetamab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "830f3ac69204e150", "summary": "Myeloma, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, with disease progression on the last therapy", "to": "At least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and demonstrated disease progression on the last therapy" } ] } ] }, { "key": "talazoparib__talzenna", "brand": "Talzenna", "inn": "talazoparib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "f811150478450986", "summary": "Breast, germline BRCA1/2-mutations, HER2-negative, Advanced, Monotherapy", "fields": [ { "field": "line_of_therapy", "from": "2L", "to": "any" }, { "field": "diagnostic_criterion", "from": "germline BRCA1/2 mutation", "to": "germline BRCA1/2-mutations" }, { "field": "prior_therapy", "from": "prior anthracycline and/or taxane in the (neo)adjuvant, locally advanced or metastatic setting (unless unsuitable); prior endocrine-based therapy for HR-positive disease (unless unsuitable)", "to": "Previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless not suitable; prior endocrine-based therapy for HR-positive breast cancer unless considered unsuitable" }, { "field": "review_fields", "from": [ "line_of_therapy" ], "to": [] } ] }, { "id": "2cd6b21016de71c7", "summary": "Prostate, no biomarker required, 1st line, metastatic, + enzalutamide", "fields": [ { "field": "line_of_therapy", "from": "any", "to": "1L" }, { "field": "patient_eligibility", "from": "chemotherapy is not clinically indicated", "to": "Chemotherapy is not clinically indicated" } ] } ] }, { "key": "erlotinib__tarceva", "brand": "Tarceva", "inn": "erlotinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "a2e74aff883c4e66", "summary": "NSCLC, EGFR mutation, 1st line, advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "EGFR activating mutations", "to": "activating mutations" } ] }, { "id": "47af145de0759ca6", "summary": "NSCLC, EGFR mutation, Maintenance, advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "EGFR activating mutations", "to": "activating mutations" } ] }, { "id": "fa0878c0e0614235", "summary": "NSCLC, EGFR mutation, 2nd line, advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "EGFR activating mutations", "to": "activating mutations" }, { "field": "prior_therapy", "from": "at least one prior chemotherapy regimen", "to": "after failure of at least one prior chemotherapy regimen" } ] }, { "id": "73e7ed522f25a3e6", "summary": "NSCLC, EGFR negative, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least one prior chemotherapy regimen", "to": "after failure of at least one prior chemotherapy regimen" } ] } ] }, { "key": "bexarotene__targretin", "brand": "Targretin", "inn": "bexarotene", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "d5340ccaa994e73e", "summary": "T-cell lymphoma, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least one systemic treatment", "to": "At least one systemic treatment" }, { "field": "patient_eligibility", "from": "skin manifestations", "to": "Skin manifestations" } ] } ] }, { "key": "nilotinib__tasigna", "brand": "Tasigna", "inn": "nilotinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "a7e2260785f975d9", "summary": "CML, Philadelphia chromosome positive, 1st line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "chronic myelogenous leukaemia (chronic phase)", "to": "chronic myelogenous leukaemia" }, { "field": "biomarker_name", "from": "BCR-ABL", "to": "BCR::ABL1" }, { "field": "biomarker_detail", "from": "Philadelphia chromosome positive", "to": "Philadelphia chromosome-positive" }, { "field": "patient_eligibility", "from": null, "to": "Chronic phase" } ] } ], "reworded": [ { "id": "e1d74840bcde3b42", "summary": "CML, Philadelphia chromosome positive, 2nd line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "chronic myelogenous leukaemia (chronic phase or accelerated phase)", "to": "chronic myelogenous leukaemia" }, { "field": "biomarker_name", "from": "BCR-ABL", "to": "BCR::ABL1" }, { "field": "biomarker_detail", "from": "Philadelphia chromosome positive", "to": "Philadelphia chromosome-positive" }, { "field": "prior_therapy", "from": "prior therapy including imatinib", "to": "Resistance or intolerance to prior therapy including imatinib" }, { "field": "patient_eligibility", "from": "resistance or intolerance to prior therapy", "to": "Chronic phase or accelerated phase" } ] }, { "id": "b2a77c2049de9c7a", "summary": "CML, Philadelphia chromosome positive, 2nd line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "chronic myelogenous leukaemia (chronic phase)", "to": "chronic myelogenous leukaemia" }, { "field": "biomarker_name", "from": "BCR-ABL", "to": "BCR::ABL1" }, { "field": "biomarker_detail", "from": "Philadelphia chromosome positive", "to": "Philadelphia chromosome-positive" }, { "field": "prior_therapy", "from": "prior therapy including imatinib", "to": "Resistance or intolerance to prior therapy including imatinib" }, { "field": "patient_eligibility", "from": "resistance or intolerance to prior therapy", "to": "Chronic phase" } ] } ] }, { "key": "brexucabtagene-autoleucel__tecartus", "brand": "Tecartus", "inn": "brexucabtagene autoleucel", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "f797978f83e2bd85", "summary": "ALL, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": null, "to": "26 years of age and above" } ] } ], "reworded": [ { "id": "bebfa56a09b8a9ff", "summary": "MCL, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor", "to": "Two or more lines of systemic therapy including a BTK inhibitor" } ] } ] }, { "key": "atezolizumab__tecentriq", "brand": "Tecentriq", "inn": "atezolizumab", "status": "changed", "labelChanged": false, "added": [ { "id": "14750b1e6421ad00", "summary": "NSCLC, EGFR/ALK-negative, 1st line, metastatic, + bevacizumab, paclitaxel and carboplatin" } ], "removed": [ { "id": "666fc6173cb7dece", "summary": "NSCLC, no biomarker required, 1st line, metastatic, + bevacizumab, paclitaxel and carboplatin" } ], "changed": [ { "id": "68036066812bdbce", "summary": "Urothelial, PD-L1 IC ≥ 5%, Advanced, Monotherapy", "fields": [ { "field": "line_of_therapy", "from": "1L", "to": "any" }, { "field": "review_fields", "from": [ "line_of_therapy" ], "to": [] } ] }, { "id": "3479f7085e6d9b6b", "summary": "NSCLC, PD-L1 expression on ≥ 50% TC, EGFR/ALK-negative, Adjuvant, early, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "PD-L1 expression on ≥ 50% of tumour cells (TC); EGFR-wild-type and ALK-negative", "to": "PD-L1 expression on ≥ 50% TC; EGFR/ALK-negative" }, { "field": "prior_therapy", "from": "complete resection and platinum-based chemotherapy", "to": "following complete resection and platinum-based chemotherapy" }, { "field": "review_fields", "from": [], "to": [ "disease_stage" ] } ] }, { "id": "e3aa34c660128236", "summary": "HCC, no biomarker required, 1st line, advanced, + bevacizumab", "fields": [ { "field": "tumor_type", "from": "hepatocellular carcinoma", "to": "hepatocellular carcinoma (HCC)" }, { "field": "prior_therapy", "from": null, "to": "no prior systemic therapy" } ] } ], "reworded": [ { "id": "d21c03a1a3f7d504", "summary": "Urothelial, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior platinum-containing chemotherapy", "to": "after prior platinum-containing chemotherapy" } ] }, { "id": "d280eebb2b4370de", "summary": "NSCLC, EGFR mutation, 2nd line, metastatic, + bevacizumab, paclitaxel and carboplatin", "fields": [ { "field": "tumor_type", "from": "EGFR-mutant or ALK-positive non-squamous NSCLC", "to": "non-squamous NSCLC" }, { "field": "biomarker_detail", "from": "EGFR-mutant or ALK-positive", "to": "EGFR-mutant" }, { "field": "diagnostic_criterion", "from": "presence of EGFR mutation or ALK fusion", "to": "EGFR mutation" }, { "field": "prior_therapy", "from": "failure of appropriate targeted therapies", "to": "after failure of appropriate targeted therapies" } ] }, { "id": "db071bc005355a0f", "summary": "NSCLC, ALK fusion, 2nd line, metastatic, + bevacizumab, paclitaxel and carboplatin", "fields": [ { "field": "diagnostic_criterion", "from": "Presence of ALK-positive NSCLC", "to": "ALK positive" } ] }, { "id": "72f88d296eb9e9c6", "summary": "NSCLC, EGFR/ALK-negative, 1st line, metastatic, + nab-paclitaxel and carboplatin", "fields": [ { "field": "biomarker_detail", "from": "EGFR and ALK wild-type / negative", "to": "EGFR/ALK-negative" }, { "field": "diagnostic_criterion", "from": "absence of EGFR mutations and ALK fusions", "to": "n/a" } ] }, { "id": "1bcfec6cc0b2a362", "summary": "NSCLC, PD-L1 expression ≥ 50% TC or ≥ 10% IC, EGFR/ALK-negative, 1st line, metastatic, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "PD-L1 expression ≥ 50% TC or ≥ 10% IC; EGFR and ALK wild-type / negative", "to": "PD-L1 expression ≥ 50% TC or ≥ 10% IC; EGFR/ALK-negative" } ] }, { "id": "18e010451586c6b5", "summary": "NSCLC, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior chemotherapy; prior targeted therapy if EGFR-mutant or ALK-positive", "to": "after prior chemotherapy; patients with EGFR-mutant or ALK-positive NSCLC should also have received targeted therapies" } ] }, { "id": "fd945770ac441599", "summary": "SCLC, no biomarker required, 1st line, advanced, + carboplatin and etoposide", "fields": [ { "field": "tumor_type", "from": "small cell lung cancer", "to": "extensive-stage small cell lung cancer (ES-SCLC)" } ] }, { "id": "050505d035e18e46", "summary": "TNBC, PD-L1 IC ≥ 1%, 1st line, advanced, + nab-paclitaxel", "fields": [ { "field": "tumor_type", "from": "triple-negative breast cancer", "to": "triple-negative breast cancer (TNBC)" } ] } ] }, { "key": "teclistamab__tecvayli", "brand": "Tecvayli", "inn": "teclistamab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "022133e7224de7a3", "summary": "Myeloma, no biomarker required, 2nd line, + daratumumab", "fields": [ { "field": "prior_therapy", "from": "at least one prior therapy", "to": "At least one prior therapy" }, { "field": "patient_eligibility", "from": null, "to": "Relapsed or refractory" } ] }, { "id": "289b3a7c41f0e785", "summary": "Myeloma, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and disease progression on the last therapy", "to": "At least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody; disease progression on the last therapy" }, { "field": "patient_eligibility", "from": null, "to": "Relapsed and refractory" } ] } ] }, { "key": "epcoritamab__tepkinly", "brand": "Tepkinly", "inn": "epcoritamab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "89208b8e778eb1b9", "summary": "FL, no biomarker required, 2nd line, + lenalidomide and rituximab", "fields": [ { "field": "prior_therapy", "from": "prior therapy", "to": null } ] } ], "reworded": [ { "id": "4a11eedfc7fc215e", "summary": "LBCL/DLBCL, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "two or more lines of systemic therapy", "to": "after two or more lines of systemic therapy" } ] }, { "id": "12db1df2f8e4d95e", "summary": "FL, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "two or more lines of systemic therapy", "to": "after two or more lines of systemic therapy" } ] } ] }, { "key": "tepotinib__tepmetko", "brand": "Tepmetko", "inn": "tepotinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "2c428db3c11bff5c", "summary": "NSCLC, leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, 2nd line, advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "non-small cell lung cancer", "to": "NSCLC" }, { "field": "diagnostic_criterion", "from": "alterations leading to METex14 skipping", "to": "alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping" } ] } ] }, { "key": "tislelizumab__tevimbra", "brand": "Tevimbra", "inn": "tislelizumab", "status": "changed", "labelChanged": true, "added": [ { "id": "6182240e240f5283", "summary": "NSCLC, no biomarker required, 1st line, advanced, + carboplatin and paclitaxel or nab-paclitaxel" } ], "removed": [ { "id": "d19969b7435ae348", "summary": "NSCLC, no biomarker required, 1st line, + carboplatin and either paclitaxel or nab-paclitaxel" } ], "changed": [], "reworded": [ { "id": "71c61fdd671eafb3", "summary": "NSCLC, no biomarker required, Neoadjuvant, early, + platinum-containing chemotherapy", "fields": [ { "field": "patient_eligibility", "from": "high risk of recurrence", "to": "High risk of recurrence" } ] }, { "id": "258c80c2cd5cba2b", "summary": "NSCLC, no biomarker required, Adjuvant, early, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "neoadjuvant tislelizumab + platinum-containing chemotherapy and surgical resection", "to": "Neoadjuvant tislelizumab + platinum-containing chemotherapy and surgical resection" }, { "field": "patient_eligibility", "from": "high risk of recurrence", "to": "High risk of recurrence" } ] }, { "id": "221102006ccd2f4a", "summary": "NSCLC, PD-L1 expression on ≥ 50% of tumour cells, EGFR/ALK-negative, 1st line, advanced, + pemetrexed and platinum-containing chemotherapy", "fields": [ { "field": "biomarker_detail", "from": "PD-L1 expression ≥50%; EGFR/ALK wild-type", "to": "PD-L1 expression on ≥ 50% of tumour cells; EGFR/ALK-negative" }, { "field": "diagnostic_criterion", "from": "PD-L1 expression on ≥50% of tumour cells", "to": "PD-L1 expression on ≥ 50% of tumour cells" }, { "field": "patient_eligibility", "from": "not candidates for surgical resection or platinum-based chemoradiation (if locally advanced)", "to": "For locally advanced disease: not candidates for surgical resection or platinum-based chemoradiation" } ] }, { "id": "40c8140c8481ff71", "summary": "NSCLC, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior platinum-based therapy; prior targeted therapies if EGFR mutant or ALK positive", "to": "Prior platinum-based therapy; patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies" } ] }, { "id": "cff2d64ff2fc5884", "summary": "SCLC, no biomarker required, 1st line, advanced, + etoposide and platinum chemotherapy", "fields": [ { "field": "tumor_type", "from": "extensive-stage small cell lung cancer", "to": "SCLC" } ] }, { "id": "5bc896892aed6bb7", "summary": "Oesophageal, PD-L1 TAP score ≥ 5%, 1st line, advanced, + platinum-based chemotherapy", "fields": [ { "field": "tumor_type", "from": "esophageal squamous cell carcinoma", "to": "oesophageal squamous cell carcinoma" } ] }, { "id": "969c5fd7f6e05fff", "summary": "Oesophageal, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "esophageal squamous cell carcinoma", "to": "oesophageal squamous cell carcinoma" }, { "field": "prior_therapy", "from": "prior platinum-based chemotherapy", "to": "Prior platinum-based chemotherapy" } ] }, { "id": "ec8c607c44cca969", "summary": "NPC, no biomarker required, 1st line, advanced, + gemcitabine and cisplatin", "fields": [ { "field": "patient_eligibility", "from": "not amenable to curative surgery or radiotherapy (if recurrent)", "to": "Recurrent disease not amenable to curative surgery or radiotherapy" } ] } ] }, { "key": "thalidomide__thalidomide-bms-previously-thalidomide-celgene-", "brand": "Thalidomide BMS (previously Thalidomide Celgene)", "inn": "thalidomide", "status": "added", "labelChanged": false, "added": [ { "id": "10c517cb7cd27b24", "summary": "Myeloma, no biomarker required, 1st line, + melphalan and prednisone" } ], "removed": [], "changed": [] }, { "key": "thalidomide__thalidomide-lipomed", "brand": "Thalidomide Lipomed", "inn": "thalidomide", "status": "added", "labelChanged": false, "added": [ { "id": "398016140df22350", "summary": "Myeloma, no biomarker required, 1st line, + melphalan and prednisone" } ], "removed": [], "changed": [] }, { "key": "ivosidenib__tibsovo", "brand": "Tibsovo", "inn": "ivosidenib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "a277d788858f1698", "summary": "AML, IDH1 R132, 1st line, + azacitidine", "fields": [ { "field": "biomarker_detail", "from": "R132", "to": "R132 mutation" }, { "field": "diagnostic_criterion", "from": "IDH1 R132 mutation", "to": "presence of IDH1 R132 mutation" }, { "field": "patient_eligibility", "from": "ineligible to receive standard induction chemotherapy", "to": "not eligible to receive standard induction chemotherapy" } ] }, { "id": "748a3dfc91e07785", "summary": "BTC, IDH1 R132, 2nd line, advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "R132", "to": "R132 mutation" }, { "field": "diagnostic_criterion", "from": "IDH1 R132 mutation", "to": "presence of IDH1 R132 mutation" } ] } ], "piUpdated": [ null, "2026-02-25" ] }, { "key": "tisotumab-vedotin__tivdak", "brand": "Tivdak", "inn": "tisotumab vedotin", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "a649097104ff9d48", "summary": "Cervical, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "systemic therapy", "to": "disease progression on or after systemic therapy" } ] } ] }, { "key": "arsenic-trioxide__trisenox", "brand": "Trisenox", "inn": "arsenic trioxide", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "e061045abf357ebe", "summary": "AML, t(15;17) translocation or PML/RAR-alpha gene, Induction, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "t(15;17) translocation and/or PML/RAR-alpha gene", "to": "t(15;17) translocation or PML/RAR-alpha gene" }, { "field": "diagnostic_criterion", "from": "presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene", "to": "presence of the t(15;17) translocation and/or the presence of the PML/RAR-alpha gene" }, { "field": "prior_therapy", "from": "previous treatment including a retinoid and chemotherapy", "to": "previous treatment should have included a retinoid and chemotherapy" } ] }, { "id": "1e4a25102d1c0a21", "summary": "AML, PML::RARA fusion (defines the disease), Consolidation, + all-trans-retinoic acid (ATRA)", "fields": [ { "field": "patient_eligibility", "from": "newly diagnosed; low-to-intermediate risk; white blood cell count ≤ 10 x 103/μl", "to": "Newly diagnosed; low-to-intermediate risk; white blood cell count ≤ 10 x 103/μl" } ] }, { "id": "8f84394ea60654ce", "summary": "AML, t(15;17) translocation and/or PML/RAR-alpha gene, Consolidation, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "previous treatment including a retinoid and chemotherapy", "to": "Previous treatment should have included a retinoid and chemotherapy" }, { "field": "patient_eligibility", "from": "relapsed or refractory", "to": "Relapsed/refractory" } ] } ] }, { "key": "sacituzumab-govitecan__trodelvy", "brand": "Trodelvy", "inn": "sacituzumab govitecan", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "b61d47fa91e89348", "summary": "TNBC, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "line_of_therapy", "from": "3L+", "to": "2L" }, { "field": "prior_therapy", "from": "two or more prior systemic therapies, including at least one of them for advanced disease", "to": "Two or more prior systemic therapies, including at least one of them for advanced disease" } ] } ], "reworded": [ { "id": "8890a2742b42e94d", "summary": "TNBC, no biomarker required, 1st line, advanced, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "not candidates for PD-1 or PD-L1 inhibitor therapy", "to": "Not candidates for PD-1 or PD-L1 inhibitor therapy" } ] }, { "id": "4691e2ce9df16ecf", "summary": "Breast, Hormone receptor-positive, HER2-negative, 3rd line+, advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "breast cancer", "to": "HR-positive, HER2-negative breast cancer" }, { "field": "diagnostic_criterion", "from": "HR-positive; HER2-negative", "to": "n/a" }, { "field": "prior_therapy", "from": "endocrine-based therapy, and at least two additional systemic therapies in the advanced setting", "to": "Endocrine-based therapy, and at least two additional systemic therapies in the advanced setting" } ] } ] }, { "key": "capivasertib__truqap", "brand": "Truqap", "inn": "capivasertib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "9c5ef84aabf310c2", "summary": "Breast, one or more PIK3CA/AKT1/PTEN-alterations, ER-positive, HER2-negative, 2nd line, advanced, + fulvestrant", "fields": [ { "field": "biomarker_detail", "from": "one or more PIK3CA/AKT1/PTEN alterations; ER-positive; HER2-negative", "to": "one or more PIK3CA/AKT1/PTEN-alterations; ER-positive; HER2-negative" }, { "field": "diagnostic_criterion", "from": "one or more PIK3CA/AKT1/PTEN-alterations; ER-positive; HER2-negative", "to": "presence of one or more PIK3CA/AKT1/PTEN-alterations" }, { "field": "prior_therapy", "from": "recurrence or progression on or after an endocrine-based regimen", "to": "Recurrence or progression on or after an endocrine-based regimen" }, { "field": "patient_eligibility", "from": null, "to": "In pre- or perimenopausal women, TRUQAP plus fulvestrant should be combined with a LHRH agonist; for men, administration of LHRH agonist according to current clinical practice standards should be considered" } ] } ] }, { "key": "tucatinib__tukysa", "brand": "Tukysa", "inn": "tucatinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "d71f8a5ec4bd35da", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, 3rd line+, advanced, + trastuzumab and capecitabine", "fields": [ { "field": "prior_therapy", "from": "at least 2 prior anti-HER2 treatment regimens", "to": "At least 2 prior anti-HER2 treatment regimens" } ] } ] }, { "key": "trastuzumab__tuznue", "brand": "Tuznue", "inn": "trastuzumab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "54f11ef636cda02e", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, 3rd line+, metastatic, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least two chemotherapy regimens for metastatic disease, including at least an anthracycline and a taxane (unless unsuitable)", "to": "At least two chemotherapy regimens for metastatic disease (including an anthracycline and a taxane unless unsuitable); hormone receptor-positive patients must have failed hormonal therapy unless unsuitable" }, { "field": "patient_eligibility", "from": "Hormone receptor positive patients must have failed hormonal therapy unless unsuitable; patients unsuitable for anthracyclines and taxanes are eligible without them", "to": null } ] }, { "id": "5745539b77ee539a", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, 1st line, metastatic, + paclitaxel", "fields": [ { "field": "prior_therapy", "from": null, "to": "No prior chemotherapy for metastatic disease" }, { "field": "patient_eligibility", "from": "anthracycline is not suitable", "to": "Anthracycline is not suitable" } ] }, { "id": "029219a090c8f6a4", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, 1st line, metastatic, + docetaxel", "fields": [ { "field": "prior_therapy", "from": null, "to": "No prior chemotherapy for metastatic disease" } ] }, { "id": "cd6350b7ebadafb8", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, Adjuvant, early, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable)", "to": "Surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable)" }, { "field": "review_fields", "from": [ "treatment_phase" ], "to": [] } ] }, { "id": "ca1cdbf48207220c", "summary": "Gastric/GEJ, HER2 IHC 3+ or IHC 2+ and confirmatory SISH or FISH, 1st line, metastatic, + capecitabine or 5-fluorouracil, and cisplatin", "fields": [ { "field": "tumor_type", "from": "gastric or gastro-oesophageal junction adenocarcinoma", "to": "adenocarcinoma of the stomach or gastro-oesophageal junction" }, { "field": "biomarker_detail", "from": "HER2-positive", "to": "HER2 overexpression" }, { "field": "diagnostic_criterion", "from": "IHC 3+ or IHC 2+/ISH-positive", "to": "IHC 3+ or IHC 2+ and confirmatory SISH or FISH" }, { "field": "prior_therapy", "from": null, "to": "No prior anti-cancer treatment for metastatic disease" } ] } ], "reworded": [ { "id": "842ee8c713d61999", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, HR-positive, Metastatic, + an aromatase inhibitor", "fields": [ { "field": "prior_therapy", "from": "no prior trastuzumab", "to": "No prior trastuzumab" }, { "field": "patient_eligibility", "from": "postmenopausal", "to": "Postmenopausal" } ] }, { "id": "544ec9760d002140", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, Adjuvant, early, + paclitaxel or docetaxel", "fields": [ { "field": "prior_therapy", "from": "adjuvant chemotherapy with doxorubicin and cyclophosphamide", "to": "Adjuvant chemotherapy with doxorubicin and cyclophosphamide" } ] }, { "id": "38bdb9b40328ab8c", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, Neoadjuvant, + neoadjuvant chemotherapy", "fields": [ { "field": "patient_eligibility", "from": "locally advanced (including inflammatory) disease or tumours > 2 cm in diameter", "to": "Locally advanced (including inflammatory) disease or tumours > 2 cm in diameter" } ] }, { "id": "f0f2e74d4f564947", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, Adjuvant, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "neoadjuvant Tuznue + chemotherapy and surgical resection", "to": "Neoadjuvant Tuznue + chemotherapy and surgical resection" }, { "field": "patient_eligibility", "from": "locally advanced (including inflammatory) disease or tumours > 2 cm in diameter", "to": "Locally advanced (including inflammatory) disease or tumours > 2 cm in diameter" } ] } ], "piUpdated": [ null, "2026-07-14" ] }, { "key": "lapatinib__tyverb", "brand": "Tyverb", "inn": "lapatinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "41b8767f36dd3d82", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, HR-positive, Metastatic, + an aromatase inhibitor", "fields": [ { "field": "biomarker_name", "from": "HER2", "to": "ERBB2" }, { "field": "prior_therapy", "from": "No prior trastuzumab or aromatase inhibitor", "to": null }, { "field": "patient_eligibility", "from": "postmenopausal; not currently intended for chemotherapy", "to": "Postmenopausal women; not currently intended for chemotherapy" } ] } ], "reworded": [ { "id": "ddc90dbc1b64380b", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, 2nd line, advanced, + capecitabine", "fields": [ { "field": "prior_therapy", "from": "prior therapy including anthracyclines, taxanes, and trastuzumab in the metastatic setting", "to": "Progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting" } ] }, { "id": "d4b66df7ea5db85e", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, HR-negative, 2nd line, metastatic, + trastuzumab", "fields": [ { "field": "prior_therapy", "from": "prior trastuzumab therapy(ies) in combination with chemotherapy", "to": "Progressed on prior trastuzumab therapy(ies) in combination with chemotherapy" } ] } ] }, { "key": "quizartinib__vanflyta", "brand": "Vanflyta", "inn": "quizartinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "00dea867d50b1232", "summary": "AML, FLT3-ITD, Induction, + standard cytarabine and anthracycline induction chemotherapy", "fields": [ { "field": "combination", "from": "+ cytarabine and anthracycline", "to": "+ standard cytarabine and anthracycline induction chemotherapy" } ] }, { "id": "4edf6bf8c5163449", "summary": "AML, FLT3-ITD, Consolidation, + standard cytarabine consolidation chemotherapy", "fields": [ { "field": "combination", "from": "+ cytarabine", "to": "+ standard cytarabine consolidation chemotherapy" }, { "field": "prior_therapy", "from": "quizartinib + standard cytarabine and anthracycline induction", "to": "quizartinib + standard cytarabine and anthracycline induction chemotherapy" } ] } ], "reworded": [ { "id": "cb9c18b595637992", "summary": "AML, FLT3-ITD, Maintenance, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "quizartinib + cytarabine and anthracycline induction and cytarabine consolidation chemotherapy", "to": "Quizartinib + standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy without progression" } ] } ], "piUpdated": [ null, "2026-08-19" ] }, { "key": "panitumumab__vectibix", "brand": "Vectibix", "inn": "panitumumab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "dc9f6bf482158608", "summary": "CRC, wild-type RAS, 1st line, metastatic, + FOLFOX or FOLFIRI", "fields": [ { "field": "diagnostic_criterion", "from": "n/a", "to": "wild-type RAS" } ] }, { "id": "3e522aff66e61413", "summary": "CRC, wild-type RAS, 2nd line, metastatic, + FOLFIRI", "fields": [ { "field": "diagnostic_criterion", "from": "n/a", "to": "wild-type RAS" }, { "field": "prior_therapy", "from": "first-line fluoropyrimidine-based chemotherapy (excluding irinotecan)", "to": "First-line fluoropyrimidine-based chemotherapy (excluding irinotecan)" } ] }, { "id": "b5861932f04c3635", "summary": "CRC, wild-type RAS, 3rd line+, metastatic, Monotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "n/a", "to": "wild-type RAS" }, { "field": "prior_therapy", "from": "failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens", "to": "Failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens" } ] } ] }, { "key": "bortezomib__velcade", "brand": "Velcade", "inn": "bortezomib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "3fa00bf15dc19734", "summary": "Myeloma, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least 1 prior therapy", "to": "At least 1 prior therapy" }, { "field": "patient_eligibility", "from": "unsuitable for haematopoietic stem cell transplantation, or have already undergone haematopoietic stem cell transplantation", "to": "Progressive disease; have already undergone or are unsuitable for haematopoietic stem cell transplantation" } ] }, { "id": "4bddae37e01d7ed2", "summary": "Myeloma, no biomarker required, 2nd line, + pegylated liposomal doxorubicin or dexamethasone", "fields": [ { "field": "prior_therapy", "from": "at least 1 prior therapy", "to": "At least 1 prior therapy" }, { "field": "patient_eligibility", "from": "unsuitable for haematopoietic stem cell transplantation, or have already undergone haematopoietic stem cell transplantation", "to": "Progressive disease; have already undergone or are unsuitable for haematopoietic stem cell transplantation" } ] }, { "id": "6f2d91e57eb60deb", "summary": "Myeloma, no biomarker required, 1st line, + melphalan and prednisone", "fields": [ { "field": "patient_eligibility", "from": "not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation", "to": "Ineligible for high-dose chemotherapy with haematopoietic stem cell transplantation" } ] }, { "id": "ffb155e2189f3191", "summary": "Myeloma, no biomarker required, Induction, + dexamethasone, or with dexamethasone and thalidomide", "fields": [ { "field": "patient_eligibility", "from": "eligible for high-dose chemotherapy with haematopoietic stem cell transplantation", "to": "Eligible for high-dose chemotherapy with haematopoietic stem cell transplantation" } ] }, { "id": "e6380c0d6629dace", "summary": "MCL, no biomarker required, 1st line, + rituximab, cyclophosphamide, doxorubicin and prednisone", "fields": [ { "field": "patient_eligibility", "from": "unsuitable for haematopoietic stem cell transplantation", "to": "Unsuitable for haematopoietic stem cell transplantation" } ] } ] }, { "key": "venetoclax__venclyxto", "brand": "Venclyxto", "inn": "venetoclax", "status": "changed", "labelChanged": false, "added": [ { "id": "1da9ba60b5e5ef81", "summary": "CLL, absence of 17p deletion or TP53 mutation, 3rd line+, Monotherapy" } ], "removed": [ { "id": "62ccc7cd083b5301", "summary": "CLL, absence of 17p deletion and TP53 mutation, 3rd line+, Monotherapy" } ], "changed": [ { "id": "26904f2f306786bd", "summary": "CLL, 17p deletion or TP53 mutation, Any line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "failed a B-cell receptor pathway inhibitor (if pretreated)", "to": "unsuitable for or have failed a B-cell receptor pathway inhibitor" }, { "field": "patient_eligibility", "from": "unsuitable for a B-cell receptor pathway inhibitor (if BCRi-naive)", "to": null } ] } ] }, { "key": "abemaciclib__verzenios", "brand": "Verzenios", "inn": "abemaciclib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "165e590ecf84de11", "summary": "Breast, Hormone receptor-positive, HER2-negative, 1st line, advanced, + an aromatase inhibitor or fulvestrant", "fields": [ { "field": "diagnostic_criterion", "from": "HR-positive", "to": "n/a" }, { "field": "patient_eligibility", "from": null, "to": "Women; In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist" } ] }, { "id": "dabe843031460237", "summary": "Breast, Hormone receptor-positive, HER2-negative, 2nd line, advanced, + an aromatase inhibitor or fulvestrant", "fields": [ { "field": "diagnostic_criterion", "from": "HR-positive", "to": "n/a" }, { "field": "prior_therapy", "from": "prior endocrine therapy", "to": "Prior endocrine therapy" }, { "field": "patient_eligibility", "from": null, "to": "Women; In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist" } ] } ], "reworded": [ { "id": "25c902e83791abaf", "summary": "Breast, Hormone receptor-positive, HER2-negative, Adjuvant, early, + endocrine therapy", "fields": [ { "field": "diagnostic_criterion", "from": "HR-positive", "to": "n/a" }, { "field": "patient_eligibility", "from": "node-positive; high risk of recurrence", "to": "node-positive; high risk of recurrence; In pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist" } ] } ] }, { "key": "larotrectinib__vitrakvi", "brand": "Vitrakvi", "inn": "larotrectinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "bd235794ccb5ed87", "summary": "Tumour-agnostic, NTRK fusion, Any line, Monotherapy", "fields": [ { "field": "disease_stage", "from": "advanced", "to": "any" }, { "field": "patient_eligibility", "from": "where surgical resection is likely to result in severe morbidity; no satisfactory treatment options", "to": "Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options" } ] } ] }, { "key": "dacomitinib__vizimpro", "brand": "Vizimpro", "inn": "dacomitinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "79b496b9fc1fee79", "summary": "NSCLC, EGFR-activating mutation, 1st line, advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "NSCLC", "to": "non-small cell lung cancer" } ] } ] }, { "key": "vorasidenib__voranigo", "brand": "Voranigo", "inn": "vorasidenib", "status": "changed", "labelChanged": false, "added": [ { "id": "376ca6554664c417", "summary": "Glioma, IDH2 R172, Any line, Monotherapy" }, { "id": "bbc87fe45faa0fa4", "summary": "Glioma, IDH2 R172, Any line, Monotherapy" } ], "removed": [], "changed": [ { "id": "462636a093f42c53", "summary": "Glioma, IDH1 R132 or IDH2 R172, 1st line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "Grade 2 astrocytoma", "to": "predominantly non-enhancing Grade 2 astrocytoma" }, { "field": "prior_therapy", "from": "surgical intervention only", "to": "Surgical intervention only" }, { "field": "patient_eligibility", "from": "predominantly non-enhancing; body weight ≥ 40 kg; not in immediate need of radiotherapy or chemotherapy", "to": "aged 12 years and older; weighing at least 40 kg; not in immediate need of radiotherapy or chemotherapy" }, { "field": "review_fields", "from": [], "to": [ "biomarker_detail" ] } ] }, { "id": "de4e2320769d8c0c", "summary": "Glioma, IDH1 R132 or IDH2 R172, 1st line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "Grade 2 oligodendroglioma", "to": "predominantly non-enhancing Grade 2 oligodendroglioma" }, { "field": "prior_therapy", "from": "surgical intervention only", "to": "Surgical intervention only" }, { "field": "patient_eligibility", "from": "predominantly non-enhancing; body weight ≥ 40 kg; not in immediate need of radiotherapy or chemotherapy", "to": "aged 12 years and older; weighing at least 40 kg; not in immediate need of radiotherapy or chemotherapy" }, { "field": "review_fields", "from": [], "to": [ "biomarker_detail" ] } ] } ] }, { "key": "pazopanib__votrient", "brand": "Votrient", "inn": "pazopanib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "1c0d07295f560494", "summary": "RCC, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior cytokine therapy for advanced disease", "to": "Prior cytokine therapy for advanced disease" } ] }, { "id": "78aeff681444d1b7", "summary": "Sarcoma, no biomarker required, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior chemotherapy for metastatic disease or progression within 12 months after (neo) adjuvant therapy", "to": "Prior chemotherapy for metastatic disease or progression within 12 months after (neo)adjuvant therapy" }, { "field": "patient_eligibility", "from": "selective subtypes", "to": "Selective subtypes of advanced soft-tissue sarcoma" } ] } ] }, { "key": "everolimus__votubia", "brand": "Votubia", "inn": "everolimus", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "be914555f4c4763f", "summary": "Angiomyolipoma, no biomarker required, Any line, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "tuberous sclerosis complex; at risk of complications; does not require immediate surgery", "to": "Tuberous sclerosis complex; 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" } ] }, { "id": "2214e3bba975cbde", "summary": "Glioma, no biomarker required, Any line, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "tuberous sclerosis complex; requires therapeutic intervention; not amenable to surgery", "to": "Tuberous sclerosis complex; require therapeutic intervention but are not amenable to surgery" } ] } ] }, { "key": "zolbetuximab__vyloy", "brand": "Vyloy", "inn": "zolbetuximab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "e38e31ab62f80391", "summary": "Gastric/GEJ, Claudin (CLDN) 18.2 positive, HER2-negative, 1st line, advanced, + fluoropyrimidine- and platinum-containing chemotherapy", "fields": [ { "field": "biomarker_detail", "from": "CLDN18.2 positive; HER2-negative", "to": "CLDN18.2-positive; HER2-negative" }, { "field": "diagnostic_criterion", "from": "Moderate-to-strong membranous staining in ≥ 75% of tumour cells", "to": "Claudin (CLDN) 18.2 positive" } ] } ] }, { "key": "daunorubicin-cytarabine__vyxeos-liposomal-previously-vyxeos-", "brand": "Vyxeos liposomal (previously Vyxeos)", "inn": "daunorubicin;cytarabine", "status": "removed", "labelChanged": false, "added": [], "removed": [ { "id": "255b11ff490bfe66", "summary": "AML, no biomarker required, 1st line, Monotherapy" }, { "id": "7c8c781d0615a340", "summary": "AML, no biomarker required, 1st line, Monotherapy" } ], "changed": [] }, { "key": "belzutifan__welireg", "brand": "Welireg", "inn": "belzutifan", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "1d4d00abc9592f8b", "summary": "Other CNS tumours, no biomarker required, Early, Monotherapy", "fields": [ { "field": "tumor_type", "from": "VHL disease-associated central nervous system haemangioblastomas", "to": "VHL disease-associated central nervous system haemangioblastoma" }, { "field": "disease_stage", "from": "any", "to": "early" } ] }, { "id": "ed2699c04bc6a48e", "summary": "NET, no biomarker required, Early, Monotherapy", "fields": [ { "field": "tumor_type", "from": "VHL disease-associated pancreatic neuroendocrine tumours", "to": "VHL disease-associated pancreatic neuroendocrine tumour" }, { "field": "disease_stage", "from": "any", "to": "early" } ] } ], "reworded": [ { "id": "e2b4e4d63c3b9726", "summary": "RCC, no biomarker required, 3rd line+, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "two or more lines of therapy that included a PD-(L)1 inhibitor and at least two VEGF-targeted therapies", "to": "Progressed following two or more lines of therapy that included a PD-(L)1 inhibitor and at least two VEGF-targeted therapies" } ] } ] }, { "key": "crizotinib__xalkori", "brand": "Xalkori", "inn": "crizotinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "72c56dcdfb4c83ab", "summary": "T-cell lymphoma, ALK fusion, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior systemic therapy (relapsed or refractory)", "to": "Relapsed or refractory" }, { "field": "patient_eligibility", "from": null, "to": "Age ≥ 1 to < 18 years" } ] }, { "id": "5d3a1ee52b4045e1", "summary": "Other musculoskeletal tumours, ALK fusion, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior therapy (recurrent or refractory)", "to": "Recurrent or refractory" }, { "field": "patient_eligibility", "from": null, "to": "Age ≥ 1 to < 18 years" } ] } ], "reworded": [ { "id": "fc042d7fca7b4600", "summary": "NSCLC, ALK fusion, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "previously treated", "to": "Previously treated" } ] } ] }, { "key": "radium-ra223-dichloride__xofigo", "brand": "Xofigo", "inn": "radium Ra223 dichloride", "status": "added", "labelChanged": false, "added": [ { "id": "abf2da837e4428d6", "summary": "Prostate, no biomarker required, Metastatic, Monotherapy" }, { "id": "d6db0a78637da65f", "summary": "Prostate, no biomarker required, Metastatic, + LHRH analogue" } ], "removed": [], "changed": [] }, { "key": "gilteritinib__xospata", "brand": "Xospata", "inn": "gilteritinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "75b1f6c53166b3f5", "summary": "AML, FLT3 mutation, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "prior therapy for AML (relapsed or refractory)", "to": "Relapsed or refractory" } ] } ] }, { "key": "enzalutamide__xtandi", "brand": "Xtandi", "inn": "enzalutamide", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "886e512a6872aa8d", "summary": "Prostate, no biomarker required, Metastatic, + androgen deprivation therapy", "fields": [ { "field": "patient_eligibility", "from": null, "to": "Men" } ] }, { "id": "6849f0c902f5def6", "summary": "Prostate, no biomarker required, 1st line, metastatic, Monotherapy", "fields": [ { "field": "line_of_therapy", "from": "2L", "to": "1L" }, { "field": "prior_therapy", "from": "androgen deprivation therapy", "to": "Failure of androgen deprivation therapy" }, { "field": "patient_eligibility", "from": "asymptomatic or mildly symptomatic; chemotherapy is not yet clinically indicated", "to": "Men; asymptomatic or mildly symptomatic; chemotherapy is not yet clinically indicated" } ] }, { "id": "62bf8beba0d168cb", "summary": "Prostate, no biomarker required, 2nd line, metastatic, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "docetaxel therapy", "to": "Progressed on or after docetaxel therapy" }, { "field": "patient_eligibility", "from": null, "to": "Men" } ] } ], "reworded": [ { "id": "1db8831f14cbf987", "summary": "Prostate, no biomarker required, Locally advanced, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "high-risk biochemical recurrence; unsuitable for salvage-radiotherapy", "to": "Men; high-risk biochemical recurrent (BCR); unsuitable for salvage-radiotherapy" } ] }, { "id": "0c666c2b78eec92a", "summary": "Prostate, no biomarker required, Locally advanced, + androgen deprivation therapy", "fields": [ { "field": "patient_eligibility", "from": "high-risk biochemical recurrence; unsuitable for salvage-radiotherapy", "to": "Men; high-risk biochemical recurrent (BCR); unsuitable for salvage-radiotherapy" } ] }, { "id": "cd5eb4e5b0ee4158", "summary": "Prostate, no biomarker required, Locally advanced, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": "high-risk", "to": "Men; high-risk" } ] } ] }, { "key": "ipilimumab__yervoy", "brand": "Yervoy", "inn": "ipilimumab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "759c4a5f59f3fddd", "summary": "NSCLC, no sensitising EGFR mutation or ALK translocation, 1st line, metastatic, + nivolumab and 2 cycles of platinum-based chemotherapy", "fields": [ { "field": "tumor_type", "from": "NSCLC", "to": "non-small cell lung cancer" }, { "field": "diagnostic_criterion", "from": "absence of sensitising EGFR mutations and ALK translocations", "to": "no sensitising EGFR mutation or ALK translocation" } ] } ] }, { "key": "axicabtagene-ciloleucel__yescarta", "brand": "Yescarta", "inn": "axicabtagene ciloleucel", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "e5c3447228a83d04", "summary": "LBCL/DLBCL, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "diffuse large B-cell lymphoma (DLBCL)", "to": "diffuse large B-cell lymphoma" }, { "field": "prior_therapy", "from": "first-line chemoimmunotherapy", "to": "First-line chemoimmunotherapy (relapsed within 12 months from completion or refractory)" }, { "field": "patient_eligibility", "from": "relapses within 12 months from completion of, or refractory to, first-line chemoimmunotherapy", "to": null } ] }, { "id": "57ca4248e04a91db", "summary": "LBCL/DLBCL, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "high-grade B-cell lymphoma (HGBL)", "to": "high-grade B-cell lymphoma" }, { "field": "prior_therapy", "from": "first-line chemoimmunotherapy", "to": "First-line chemoimmunotherapy (relapsed within 12 months from completion or refractory)" }, { "field": "patient_eligibility", "from": "relapses within 12 months from completion of, or refractory to, first-line chemoimmunotherapy", "to": null } ] }, { "id": "5fc513464e4e1a21", "summary": "LBCL/DLBCL, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "tumor_type", "from": "diffuse large B-cell lymphoma (DLBCL)", "to": "diffuse large B-cell lymphoma" }, { "field": "prior_therapy", "from": "two or more lines of systemic therapy", "to": "Two or more lines of systemic therapy" }, { "field": "patient_eligibility", "from": "relapsed or refractory", "to": null } ] }, { "id": "b52f32b4897d4f3f", "summary": "LBCL/DLBCL, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "tumor_type", "from": "primary mediastinal large B-cell lymphoma (PMBCL)", "to": "primary mediastinal large B-cell lymphoma" }, { "field": "prior_therapy", "from": "two or more lines of systemic therapy", "to": "Two or more lines of systemic therapy" }, { "field": "patient_eligibility", "from": "relapsed or refractory", "to": null } ] }, { "id": "eedbe18349370c6e", "summary": "FL, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "tumor_type", "from": "follicular lymphoma (FL)", "to": "follicular lymphoma" }, { "field": "prior_therapy", "from": "three or more lines of systemic therapy", "to": "Three or more lines of systemic therapy" }, { "field": "patient_eligibility", "from": "relapsed or refractory", "to": null } ] } ] }, { "key": "aflibercept__zaltrap", "brand": "Zaltrap", "inn": "aflibercept", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "7bafc012b1fb5aa9", "summary": "CRC, no biomarker required, 2nd line, metastatic, + irinotecan/5-fluorouracil/folinic acid (FOLFIRI)", "fields": [ { "field": "prior_therapy", "from": "oxaliplatin-containing regimen", "to": "Oxaliplatin-containing regimen (resistant to or progressed after)" } ] } ] }, { "key": "niraparib__zejula", "brand": "Zejula", "inn": "niraparib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "94676965c630292e", "summary": "Ovarian, no biomarker required, Maintenance, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "first-line platinum-based chemotherapy", "to": "First-line platinum-based chemotherapy" }, { "field": "patient_eligibility", "from": "in response (complete or partial) following completion of first-line platinum-based chemotherapy", "to": "In complete or partial response following completion of first-line platinum-based chemotherapy; FIGO Stages III and IV" } ] }, { "id": "92d7492bb2e0ffde", "summary": "Ovarian, no biomarker required, Maintenance, advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer", "to": "high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer" }, { "field": "prior_therapy", "from": "platinum-based chemotherapy", "to": "Platinum-based chemotherapy" }, { "field": "patient_eligibility", "from": "platinum-sensitive; in response (complete or partial) to platinum-based chemotherapy", "to": "Platinum-sensitive; in complete or partial response to platinum-based chemotherapy" } ] } ] }, { "key": "vemurafenib__zelboraf", "brand": "Zelboraf", "inn": "vemurafenib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "3ddda2514e27e1a5", "summary": "Melanoma, BRAF V600, Advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "V600", "to": "V600 mutation-positive" }, { "field": "diagnostic_criterion", "from": "BRAF V600 mutation-positive", "to": "BRAF V600 mutation" } ] } ] }, { "key": "lurbinectedin__zepzelca", "brand": "Zepzelca", "inn": "lurbinectedin", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "ad412094b3fc2eb8", "summary": "SCLC, no biomarker required, Maintenance, advanced, + atezolizumab", "fields": [ { "field": "tumor_type", "from": "extensive-stage small cell lung cancer", "to": "small cell lung cancer" }, { "field": "prior_therapy", "from": "first-line induction therapy with atezolizumab, carboplatin and etoposide without progression", "to": "first-line induction therapy with atezolizumab, carboplatin and etoposide without disease progression" } ] } ] }, { "key": "zanidatamab__ziihera", "brand": "Ziihera", "inn": "zanidatamab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "a53706e6cefd3c68", "summary": "BTC, HER2-positive (IHC 3+), 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least one prior line of systemic therapy", "to": "At least one prior line of systemic therapy" } ] } ] }, { "key": "idelalisib__zydelig", "brand": "Zydelig", "inn": "idelalisib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "c08bbb0cbcac7653", "summary": "FL, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "two prior lines of treatment", "to": "refractory to two prior lines of treatment" }, { "field": "patient_eligibility", "from": "refractory to two prior lines of treatment", "to": null } ] } ] }, { "key": "ceritinib__zykadia", "brand": "Zykadia", "inn": "ceritinib", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "4cf33271c37c0b80", "summary": "NSCLC, ALK fusion, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "crizotinib", "to": "Previously treated with crizotinib" } ] } ] }, { "key": "loncastuximab-tesirine__zynlonta", "brand": "Zynlonta", "inn": "loncastuximab tesirine", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "7fec102d46f0294e", "summary": "LBCL/DLBCL, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "after two or more lines of systemic therapy", "to": "Two or more lines of systemic therapy" }, { "field": "patient_eligibility", "from": null, "to": "relapsed or refractory" } ] }, { "id": "cc1f1e6697094d40", "summary": "LBCL/DLBCL, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "after two or more lines of systemic therapy", "to": "Two or more lines of systemic therapy" }, { "field": "patient_eligibility", "from": null, "to": "relapsed or refractory" } ] } ] }, { "key": "retifanlimab__zynyz", "brand": "Zynyz", "inn": "retifanlimab", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "ff5ed26e23cff96e", "summary": "Anal, no biomarker required, 1st line, advanced, + carboplatin and paclitaxel", "fields": [ { "field": "organ", "from": "colorectal", "to": "other" } ] }, { "id": "39f8aedcd5888bb4", "summary": "Merkel cell, no biomarker required, 1st line, advanced, Monotherapy", "fields": [ { "field": "patient_eligibility", "from": null, "to": "Not amenable to curative surgery or radiation therapy" } ] } ], "piUpdated": [ null, "2026-03-18" ] }, { "key": "abiraterone__zytiga", "brand": "Zytiga", "inn": "abiraterone", "status": "changed", "labelChanged": false, "added": [], "removed": [], "changed": [ { "id": "c11594da84ccbbff", "summary": "Prostate, no biomarker required, 1st line, metastatic, + prednisone or prednisolone", "fields": [ { "field": "line_of_therapy", "from": "2L", "to": "1L" }, { "field": "prior_therapy", "from": "after failure of androgen deprivation therapy", "to": "Failure of androgen deprivation therapy" }, { "field": "patient_eligibility", "from": "asymptomatic or mildly symptomatic; chemotherapy not yet clinically indicated", "to": "Men; asymptomatic or mildly symptomatic; chemotherapy is not yet clinically indicated" } ] }, { "id": "0f22cedd4ab60249", "summary": "Prostate, no biomarker required, 2nd line, metastatic, + prednisone or prednisolone", "fields": [ { "field": "prior_therapy", "from": "docetaxel-based chemotherapy regimen", "to": "Progressed on or after a docetaxel-based chemotherapy regimen" }, { "field": "patient_eligibility", "from": null, "to": "Men" } ] } ], "reworded": [ { "id": "1286734ed88d3367", "summary": "Prostate, no biomarker required, 1st line, metastatic, + prednisone or prednisolone, and androgen deprivation therapy (ADT)", "fields": [ { "field": "combination", "from": "+ prednisone or prednisolone, and androgen deprivation therapy", "to": "+ prednisone or prednisolone, and androgen deprivation therapy (ADT)" }, { "field": "patient_eligibility", "from": "high risk", "to": "Men; newly diagnosed; high risk" } ] } ] } ] }, { "version": "ba7a304ef0", "previous": "9adf15db28", "date": "2026-10-23T17:16:13.304Z", "emaTimestamp": "2026-10-23T18:02:42Z", "products": [ { "key": "inotuzumab-ozogamicin__besponsa", "brand": "Besponsa", "inn": "inotuzumab ozogamicin", "status": "changed", "labelChanged": true, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "d603c2c5126abe1a", "summary": "ALL, CD22-positive, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "relapsed or refractory disease; for Ph+ disease, failed treatment with at least 1 tyrosine kinase inhibitor (TKI)", "to": "For Ph+ disease, failed treatment with at least 1 tyrosine kinase inhibitor (TKI)" } ] }, { "id": "f8d8dca9bd94dc73", "summary": "ALL, CD22-positive, 2nd line, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "in first relapse after allo-HSCT, after any first relapse in VHR disease, after a second or greater relapse, or refractory; for Ph+ disease: exhausted relevant BCR-ABL targeting treatment options", "to": "First relapse after allo-HSCT, or first relapse with VHR disease, or second or greater relapse, or refractory disease; exhausted relevant BCR-ABL targeting treatment options if Ph+" } ] } ] }, { "key": "zanubrutinib__brukinsa", "brand": "Brukinsa", "inn": "zanubrutinib", "status": "changed", "labelChanged": true, "added": [], "removed": [], "changed": [ { "id": "d52aee00a04c9c4a", "summary": "FL, no biomarker required, 3rd line+, + obinutuzumab", "fields": [ { "field": "patient_eligibility", "from": null, "to": "refractory or relapsed" } ] } ], "reworded": [ { "id": "39527fa4fb76b7aa", "summary": "Waldenström, no biomarker required, 2nd line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "Waldenström’s macroglobulinaemia", "to": "Waldenström's macroglobulinaemia" } ] }, { "id": "f7a3fb64c20bbe43", "summary": "Waldenström, no biomarker required, 1st line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "Waldenström’s macroglobulinaemia", "to": "Waldenström's macroglobulinaemia" } ] } ] }, { "key": "camizestrant__etcamah", "brand": "Etcamah", "inn": "camizestrant", "status": "changed", "labelChanged": true, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "3db25b546636ec2c", "summary": "Breast, ESR1-mutation, ER-positive, HER2-negative, 1st line, advanced, + a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib)", "fields": [ { "field": "diagnostic_criterion", "from": "detection of ESR1 mutation", "to": "detection of ESR1-mutation" }, { "field": "prior_therapy", "from": "first-line endocrine therapy in combination with a CDK4/6 inhibitor without disease progression", "to": "First-line endocrine therapy in combination with a CDK4/6 inhibitor" }, { "field": "patient_eligibility", "from": "pre- or peri-menopausal women and men require concomitant LHRH agonist or antagonist", "to": "Without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor; pre- or peri-menopausal women and men should be combined with an LHRH agonist or antagonist" } ] } ] }, { "key": "pembrolizumab__keytruda", "brand": "Keytruda", "inn": "pembrolizumab", "status": "changed", "labelChanged": true, "added": [], "removed": [], "changed": [ { "id": "b5c0956aca258c1c", "summary": "Hodgkin, no biomarker required, 3rd line+, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "failed ASCT, or at least two prior therapies", "to": "failed ASCT, or at least two prior therapies when ASCT is not a treatment option" }, { "field": "patient_eligibility", "from": "when ASCT is not a treatment option (for branch without ASCT)", "to": null } ] }, { "id": "92f37fddf562fc29", "summary": "TNBC, no biomarker required, Adjuvant, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "neoadjuvant pembrolizumab + chemotherapy and surgery", "to": "neoadjuvant pembrolizumab + chemotherapy and surgical resection" }, { "field": "patient_eligibility", "from": "high risk of recurrence", "to": "locally advanced, or early-stage at high risk of recurrence" } ] }, { "id": "f1c13edcf2944e1a", "summary": "Cervical, no biomarker required, 1st line, locally advanced, + chemoradiotherapy (external beam radiation therapy followed by brachytherapy)", "fields": [ { "field": "prior_therapy", "from": "no prior definitive therapy", "to": null }, { "field": "patient_eligibility", "from": "FIGO 2014 Stage III - IVA", "to": "FIGO 2014 Stage III - IVA; no prior definitive therapy" } ] }, { "id": "9dcb3b27afe28f8d", "summary": "Gastric/GEJ, PD-L1 CPS ≥ 1; HER2: IHC 3+ or IHC 2+/ISH-positive, 1st line, advanced, + trastuzumab, fluoropyrimidine and platinum-containing chemotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "CPS ≥ 1; IHC 3+ or IHC 2+/ISH-positive", "to": "CPS ≥ 1; HER2: IHC 3+ or IHC 2+/ISH-positive" }, { "field": "review_fields", "from": [], "to": [ "biomarker_name" ] } ] } ], "reworded": [ { "id": "d5ea61cd1d9e1fe1", "summary": "Melanoma, no biomarker required, Advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "cutaneous melanoma", "to": "melanoma" } ] }, { "id": "e3da205c99944d83", "summary": "Melanoma, no biomarker required, Adjuvant, Monotherapy", "fields": [ { "field": "tumor_type", "from": "cutaneous melanoma", "to": "melanoma" }, { "field": "prior_therapy", "from": "complete surgical resection", "to": "complete resection" }, { "field": "patient_eligibility", "from": "Stage IIB, IIC or III melanoma; complete resection", "to": "Stage IIB, IIC or III melanoma" } ] }, { "id": "0886ac4db5a33ab9", "summary": "NSCLC, PD-L1 TPS ≥ 50%, EGFR and ALK wild-type, 1st line, metastatic, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "TPS ≥ 50%; EGFR/ALK wild-type", "to": "TPS ≥ 50%; EGFR and ALK wild-type" } ] }, { "id": "70f046275b479c17", "summary": "NSCLC, PD-L1 TPS ≥ 1%, 2nd line, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least one prior chemotherapy regimen; targeted therapy if EGFR or ALK positive", "to": "at least one prior chemotherapy regimen; prior targeted therapy if EGFR or ALK positive" } ] }, { "id": "dd143890f5748c52", "summary": "HNSCC, PD-L1 CPS ≥ 1, Neoadjuvant, locally advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "head and neck squamous cell carcinoma", "to": "HNSCC" } ] }, { "id": "aa9990e296bdfa0d", "summary": "HNSCC, PD-L1 CPS ≥ 1, Adjuvant, locally advanced, + radiation therapy with or without concomitant cisplatin and then as monotherapy", "fields": [ { "field": "tumor_type", "from": "head and neck squamous cell carcinoma", "to": "HNSCC" }, { "field": "combination", "from": "+ radiation therapy with or without concomitant cisplatin, followed by monotherapy", "to": "in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy" } ] }, { "id": "0008005937e89870", "summary": "HNSCC, PD-L1 CPS ≥ 1, 1st line, advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "head and neck squamous cell carcinoma", "to": "HNSCC" } ] }, { "id": "95b0eeb9580b2bc8", "summary": "HNSCC, PD-L1 CPS ≥ 1, 1st line, advanced, + platinum and 5-fluorouracil (5-FU) chemotherapy", "fields": [ { "field": "tumor_type", "from": "head and neck squamous cell carcinoma", "to": "HNSCC" } ] }, { "id": "f7b9708110dcabcd", "summary": "HNSCC, PD-L1 TPS ≥ 50%, 2nd line, advanced, Monotherapy", "fields": [ { "field": "tumor_type", "from": "head and neck squamous cell carcinoma", "to": "HNSCC" } ] }, { "id": "3231a204fd7d55ce", "summary": "RCC, no biomarker required, 1st line, advanced, + axitinib", "fields": [ { "field": "tumor_type", "from": "renal cell carcinoma", "to": "RCC" } ] }, { "id": "973843ed0946ee15", "summary": "RCC, no biomarker required, 1st line, advanced, + lenvatinib", "fields": [ { "field": "tumor_type", "from": "renal cell carcinoma", "to": "RCC" } ] }, { "id": "b9dc96478b213548", "summary": "RCC, no biomarker required, Adjuvant, Monotherapy", "fields": [ { "field": "tumor_type", "from": "renal cell carcinoma", "to": "RCC" } ] }, { "id": "80dae96342ca5102", "summary": "CRC, MMR/MSI deficient, 1st line, metastatic, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "dMMR or MSI-H", "to": "MSI-H or dMMR" }, { "field": "diagnostic_criterion", "from": "dMMR or MSI-H", "to": "MSI-H or dMMR" } ] }, { "id": "5a9acb3680feff71", "summary": "CRC, MMR/MSI deficient, 2nd line, advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "dMMR or MSI-H", "to": "MSI-H or dMMR" }, { "field": "diagnostic_criterion", "from": "dMMR or MSI-H", "to": "MSI-H or dMMR" } ] }, { "id": "b665735498ad8b23", "summary": "Endometrial, MMR/MSI deficient, 2nd line, advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "dMMR or MSI-H", "to": "MSI-H or dMMR" }, { "field": "diagnostic_criterion", "from": "dMMR or MSI-H", "to": "MSI-H or dMMR" } ] }, { "id": "529394122bba790b", "summary": "Gastric/GEJ, MMR/MSI deficient, 2nd line, advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "dMMR or MSI-H", "to": "MSI-H or dMMR" }, { "field": "diagnostic_criterion", "from": "dMMR or MSI-H", "to": "MSI-H or dMMR" } ] }, { "id": "61446e491c2efff6", "summary": "Small intestine, MMR/MSI deficient, 2nd line, advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "dMMR or MSI-H", "to": "MSI-H or dMMR" }, { "field": "diagnostic_criterion", "from": "dMMR or MSI-H", "to": "MSI-H or dMMR" } ] }, { "id": "d48efb4d4a104f6e", "summary": "BTC, MMR/MSI deficient, 2nd line, advanced, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "dMMR or MSI-H", "to": "MSI-H or dMMR" }, { "field": "diagnostic_criterion", "from": "dMMR or MSI-H", "to": "MSI-H or dMMR" } ] }, { "id": "414f1a11b964eb1e", "summary": "Oesophageal, PD-L1 CPS ≥ 10, 1st line, advanced, + platinum and fluoropyrimidine-based chemotherapy", "fields": [ { "field": "tumor_type", "from": "esophageal carcinoma", "to": "carcinoma of the oesophagus" } ] }, { "id": "fcc7a2a88f38b5a8", "summary": "TNBC, no biomarker required, Neoadjuvant, + chemotherapy", "fields": [ { "field": "patient_eligibility", "from": "high risk of recurrence", "to": "locally advanced, or early-stage at high risk of recurrence" } ] } ] }, { "key": "tislelizumab__tevimbra", "brand": "Tevimbra", "inn": "tislelizumab", "status": "changed", "labelChanged": true, "added": [], "removed": [], "changed": [ { "id": "ec8c607c44cca969", "summary": "NPC, no biomarker required, 1st line, advanced, + gemcitabine and cisplatin", "fields": [ { "field": "patient_eligibility", "from": null, "to": "not amenable to curative surgery or radiotherapy (if recurrent)" } ] } ], "reworded": [ { "id": "221102006ccd2f4a", "summary": "NSCLC, PD-L1 expression ≥50%, EGFR/ALK wild-type, 1st line, advanced, + pemetrexed and platinum-containing chemotherapy", "fields": [ { "field": "biomarker_detail", "from": "PD-L1 expression on ≥ 50% of tumour cells; EGFR/ALK wild-type", "to": "PD-L1 expression ≥50%; EGFR/ALK wild-type" }, { "field": "diagnostic_criterion", "from": "TPS ≥ 50%", "to": "PD-L1 expression on ≥50% of tumour cells" } ] }, { "id": "d19969b7435ae348", "summary": "NSCLC, no biomarker required, 1st line, + carboplatin and either paclitaxel or nab-paclitaxel", "fields": [ { "field": "combination", "from": "+ carboplatin and paclitaxel or nab-paclitaxel", "to": "+ carboplatin and either paclitaxel or nab-paclitaxel" } ] }, { "id": "cff2d64ff2fc5884", "summary": "SCLC, no biomarker required, 1st line, advanced, + etoposide and platinum chemotherapy", "fields": [ { "field": "tumor_type", "from": "SCLC", "to": "extensive-stage small cell lung cancer" } ] }, { "id": "fb35b7465a75c6ed", "summary": "Gastric/GEJ, PD-L1 TAP score ≥ 5%, HER2-negative, 1st line, advanced, + platinum and fluoropyrimidine-based chemotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "TAP ≥ 5%", "to": "TAP score ≥ 5%" }, { "field": "combination", "from": "+ platinum- and fluoropyrimidine-based chemotherapy", "to": "+ platinum and fluoropyrimidine-based chemotherapy" } ] }, { "id": "5bc896892aed6bb7", "summary": "Oesophageal, PD-L1 TAP score ≥ 5%, 1st line, advanced, + platinum-based chemotherapy", "fields": [ { "field": "diagnostic_criterion", "from": "TAP ≥ 5%", "to": "TAP score ≥ 5%" } ] } ] }, { "key": "arsenic-trioxide__trisenox", "brand": "Trisenox", "inn": "arsenic trioxide", "status": "changed", "labelChanged": true, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "17842a869dd9c567", "summary": "Haematological, no biomarker required, Induction, + all-trans-retinoic acid (ATRA)", "fields": [ { "field": "patient_eligibility", "from": "low-to-intermediate risk (white blood cell count ≤ 10 x 103 /μl)", "to": "low-to-intermediate risk; white blood cell count ≤ 10 x 103/μl" } ] }, { "id": "e061045abf357ebe", "summary": "Haematological, PML::RARA the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene, 17) translocation and/or PML/RAR-alpha gene, Induction, Monotherapy", "fields": [ { "field": "biomarker_detail", "from": "t(15;17) translocation and/or PML/RAR-alpha presence", "to": "t(15;17) translocation and/or PML/RAR-alpha gene" }, { "field": "prior_therapy", "from": "previous treatment should have included a retinoid and chemotherapy", "to": "previous treatment including a retinoid and chemotherapy" } ] }, { "id": "1e4a25102d1c0a21", "summary": "Haematological, no biomarker required, Consolidation, + all-trans-retinoic acid (ATRA)", "fields": [ { "field": "patient_eligibility", "from": "newly diagnosed; low-to-intermediate risk; white blood cell count ≤ 10 x 103 /μl", "to": "newly diagnosed; low-to-intermediate risk; white blood cell count ≤ 10 x 103/μl" } ] }, { "id": "8f84394ea60654ce", "summary": "Haematological, PML::RARA 17) translocation and/or PML/RAR-alpha gene, Consolidation, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "retinoid and chemotherapy", "to": "previous treatment including a retinoid and chemotherapy" }, { "field": "patient_eligibility", "from": "relapsed/refractory", "to": "relapsed or refractory" } ] } ] }, { "key": "trastuzumab__tuznue", "brand": "Tuznue", "inn": "trastuzumab", "status": "changed", "labelChanged": true, "added": [], "removed": [], "changed": [ { "id": "54f11ef636cda02e", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, 3rd line+, metastatic, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "at least two prior chemotherapy regimens for metastatic disease (including an anthracycline and a taxane unless unsuitable); prior hormonal therapy if hormone receptor-positive (unless unsuitable)", "to": "at least two chemotherapy regimens for metastatic disease, including at least an anthracycline and a taxane (unless unsuitable)" }, { "field": "patient_eligibility", "from": null, "to": "Hormone receptor positive patients must have failed hormonal therapy unless unsuitable; patients unsuitable for anthracyclines and taxanes are eligible without them" } ] }, { "id": "ca1cdbf48207220c", "summary": "Gastric/GEJ, HER2 IHC 3+ or IHC 2+/ISH-positive, 1st line, metastatic, + capecitabine or 5-fluorouracil, and cisplatin", "fields": [ { "field": "diagnostic_criterion", "from": "IHC 3+ or IHC 2+ with confirmatory SISH or FISH", "to": "IHC 3+ or IHC 2+/ISH-positive" } ] } ], "reworded": [ { "id": "cd6350b7ebadafb8", "summary": "Breast, HER2 IHC 3+ or IHC 2+/ISH-positive, Adjuvant, early, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "surgery, neoadjuvant or adjuvant chemotherapy, and radiotherapy (if applicable)", "to": "surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable)" } ] } ] }, { "key": "belzutifan__welireg", "brand": "Welireg", "inn": "belzutifan", "status": "changed", "labelChanged": true, "added": [], "removed": [], "changed": [], "reworded": [ { "id": "e2b4e4d63c3b9726", "summary": "RCC, no biomarker required, 3rd line+, advanced, Monotherapy", "fields": [ { "field": "prior_therapy", "from": "two or more lines of therapy including a PD-(L)1 inhibitor and at least two VEGF-targeted therapies", "to": "two or more lines of therapy that included a PD-(L)1 inhibitor and at least two VEGF-targeted therapies" } ] }, { "id": "1d4d00abc9592f8b", "summary": "Other CNS tumours, no biomarker required, Any line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "VHL disease-associated central nervous system haemangioblastoma", "to": "VHL disease-associated central nervous system haemangioblastomas" } ] }, { "id": "ed2699c04bc6a48e", "summary": "NET, no biomarker required, Any line, Monotherapy", "fields": [ { "field": "tumor_type", "from": "VHL disease-associated pancreatic neuroendocrine tumour", "to": "VHL disease-associated pancreatic neuroendocrine tumours" } ] } ] }, { "key": "vemurafenib__zelboraf", "brand": "Zelboraf", "inn": "vemurafenib", "status": "changed", "labelChanged": true, "added": [], "removed": [], "changed": [] } ] }, { "version": "9adf15db28", "previous": null, "date": "2026-10-23T16:22:03.452Z", "emaTimestamp": "2026-10-23T06:01:58Z", "products": [], "baseline": { "products": 180, "entries": 625 } } ] }