Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized tislelizumab 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 tumors express PD-L1 with a tumor area positivity (TAP) score >= 5%. This indication is based on BGB-A317-305, a global, randomized, double-blind, placebo-controlled study involving 997 patients. The chemotherapy regimen consisted of either oxaliplatin and capecitabine, or cisplatin and 5-FU.

This is written in the approval document as:

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%.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	PD-L1 (TAP) >= 5%	Adenocarcinoma of the Gastroesophageal Junction	Capecitabine, Oxaliplatin, Tislelizumab
EMA (1)	PD-L1 (TAP) >= 5%	Adenocarcinoma of the Gastroesophageal Junction	Cisplatin, Fluorouracil, Tislelizumab

Contributions

Date	Contributor	Description
2025-09-05	Van Allen lab	On 2024-12-19, the EMA published an EPAR - Assessment report - Variation for Tevimbra (tislelizumab) that added an extension indication to tislelizumab in combination with platinum-based chemotherapy for the first-line treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (OSCC) whose tumours express PD-L1 with a tumor area positivity (TAP) score >= 5%.
2024-11-25	European Medicines Agency	Indication received approval from the European Commission.