Regulatory approval

Published by the Food and Drug Administration. Approved

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).

This is written in the approval document.

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