Tevimbra (tislelizumab) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

BeiGene Ireland Ltd. Tevimbra (tislelizumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf. Revised July 2025. Accessed September 5, 2025.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
Tevimbra in combination with pemetrexed and platinum-containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous NSCLC whose tumors have PD-L1 expression on >= 50% of tumor cells with no EGFR or ALK positive mutations and who have (i) locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or (ii) metastatic NSCLC.	2
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%.	6
Tevimbra, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER2-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%.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	PD-L1 >= 50%, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Pemetrexed, Tislelizumab
Sensitivity (+)	PD-L1 >= 50%, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Cisplatin, Pemetrexed, Tislelizumab
Sensitivity (+)	PD-L1 (TAP) >= 5%	Esophageal Squamous Cell Carcinoma	Cisplatin, Fluorouracil, Tislelizumab
Sensitivity (+)	PD-L1 (TAP) >= 5%	Esophageal Squamous Cell Carcinoma	Capecitabine, Cisplatin, Tislelizumab
Sensitivity (+)	PD-L1 (TAP) >= 5%	Esophageal Squamous Cell Carcinoma	Fluorouracil, Oxaliplatin, Tislelizumab
Sensitivity (+)	PD-L1 (TAP) >= 5%	Esophageal Squamous Cell Carcinoma	Capecitabine, Oxaliplatin, Tislelizumab
Sensitivity (+)	PD-L1 (TAP) >= 5%	Esophageal Squamous Cell Carcinoma	Cisplatin, Paclitaxel, Tislelizumab
Sensitivity (+)	PD-L1 (TAP) >= 5%	Esophageal Squamous Cell Carcinoma	Oxaliplatin, Paclitaxel, Tislelizumab
Sensitivity (+)	PD-L1 (TAP) >= 5%	Adenocarcinoma of the Gastroesophageal Junction	Capecitabine, Oxaliplatin, Tislelizumab
Sensitivity (+)	PD-L1 (TAP) >= 5%	Adenocarcinoma of the Gastroesophageal Junction	Cisplatin, Fluorouracil, Tislelizumab