Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration (FDA) granted approval to tislelizumab in combination with platinum and fluoropyrimidine-based chemotherapy for the first-line treatment of adult patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors are HER2-negative and express PD-L1 (>=1). This indication is based on RATIONALE-305, a randomized, multicenter, double-blind, placebo-controlled trial where the chemotherapy regimens consisting of either: oxaliplatin and capecitabine, or cisplatin and 5-FU. Patients were enrolled regardless of their tumor's PD-L1 expression level, but PD-L1 status was evaluated using both TAP and CPS criteria.

This is written in the approval document as:

TEVIMBRA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with platinum and fluoropyrimidine-based chemotherapy in adults for the first line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocracinoma whose tumors express PD-L1 (>=1).

Citation

BeOne Medicines USA, Inc. Tevimbra (tislelizumab-jsgr) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761232s013lbl.pdf. Revised December 2025. Accessed December 26, 2025.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	HER2-negative, PD-L1 (TAP) >= 1%	Adenocarcinoma of the Gastroesophageal Junction	Capecitabine, Oxaliplatin, Tislelizumab
FDA (2)	HER2-negative, PD-L1 (TAP) >= 1%	Adenocarcinoma of the Gastroesophageal Junction	Cisplatin, Fluorouracil, Tislelizumab
FDA (2)	HER2-negative, PD-L1 (CPS) >= 1	Adenocarcinoma of the Gastroesophageal Junction	Capecitabine, Oxaliplatin, Tislelizumab
FDA (2)	HER2-negative, PD-L1 (CPS) >= 1	Adenocarcinoma of the Gastroesophageal Junction	Cisplatin, Fluorouracil, Tislelizumab

Contributions

Date	Contributor	Description
2025-12-26	Van Allen lab	On 2025-04-22, the US FDA granted approval to tislelizumab in combination with platinum-containing chemotherapy for the first-line treatment of adult patients unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (>=1). Tislelizumab in combination with platinum and fluoropyrimidine-based chemotherapy was also approved for the treatment of gastric or gastroesophageal junction adenocarcinoma whose tumors are HER2-negative and express PD-L1 (>=1)
2025-04-22	Food and Drug Administration	Indication received traditional approval.