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.

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Therapeutic response

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

Organizations
Biomarkers
Cancer types
Therapies
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.