Regulatory approval

Published by the European Medicines Agency. Approved

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%.

This is written in the approval document.

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