Tislelizumab

Tislelizumab (Tevimbra, Beone Medicines Ireland Limited) has 10 EU-approved indications in 5 tumour types. 3 need a biomarker result: PD-L1 (3).
Approved indications of Tislelizumab
Biomarker requirementRegimenSettingConditions
Small cell lung cancer1
None
+ etoposide and platinum chemotherapy
1L
advanced
None
Non-small cell lung cancer5
None
+ platinum-containing chemotherapy
Neoadj.
early
Then adjuvant monotherapy after surgery; High risk of recurrence
None
Monotherapy
Adj.
early
After neoadjuvant tislelizumab + platinum-containing chemotherapy and surgical resection; High risk of recurrence
None
+ carboplatin and paclitaxel or nab-paclitaxel
1L
advanced
Squamous only; For locally advanced disease: not candidates for surgical resection or platinum-based chemoradiation
PD-L1 expression on ≥ 50% of tumour cells, EGFR/ALK-negative
+ pemetrexed and platinum-containing chemotherapy
1L
advanced
Non-squamous only; For locally advanced disease: not candidates for surgical resection or platinum-based chemoradiation
None
Monotherapy
2L
advanced
After prior platinum-based therapy; patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies
Gastric and GEJ adenocarcinoma1
PD-L1 TAP score ≥ 5%, HER2-negative
+ platinum and fluoropyrimidine-based chemotherapy
1L
advanced
None
Oesophageal cancer2
PD-L1 TAP score ≥ 5%
+ platinum-based chemotherapy
1L
advanced
Squamous cell carcinoma only
None
Monotherapy
2L
advanced
Squamous cell carcinoma only; After prior platinum-based chemotherapy
Nasopharyngeal carcinoma1
None
+ gemcitabine and cisplatin
1L
advanced
Recurrent disease not amenable to curative surgery or radiotherapy
Full text of section 4.1 (therapeutic indications)

Non-small cell lung cancer (NSCLC) Tevimbra, in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of adult patients with resectable NSCLC at high risk of recurrence (for selection criteria, see section 5.1). Tevimbra, in combination with pemetrexed and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with non-squamous NSCLC whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have: • locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or • metastatic NSCLC. Tevimbra, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of adult patients with squamous NSCLC who have: • locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or • metastatic NSCLC. Tevimbra as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab. Small Cell Lung Cancer (SCLC) Tevimbra, in combination with etoposide and platinum chemotherapy, is indicated for the first-line treatment of adult patients with extensive-stage SCLC. Gastric or gastroesophageal junction (G/GEJ) adenocarcinoma Tevimbra, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER-2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumours express PD-L1 with a tumour area positivity (TAP) score ≥ 5% (see section 5.1). Oesophageal squamous cell carcinoma (OSCC) Tevimbra, in combination with platinum-based chemotherapy, is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic OSCC whose tumours express PD-L1 with a TAP score ≥ 5% (see section 5.1). Tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic OSCC after prior platinum-based chemotherapy. Nasopharyngeal carcinoma (NPC) Tevimbra, in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of adult patients with recurrent, not amenable to curative surgery or radiotherapy, or metastatic NPC.

Label history

20 changes to the Tevimbra label since 2023, 6 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes