Tevimbra (tislelizumab-jsgr) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
TEVIMBRA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (>=1). 12
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). 4

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
FDA (1) PD-L1 (TAP) >= 1% Esophageal Squamous Cell Carcinoma Cisplatin, Fluorouracil, Tislelizumab
FDA (1) PD-L1 (TAP) >= 1% Esophageal Squamous Cell Carcinoma Capecitabine, Cisplatin, Tislelizumab
FDA (1) PD-L1 (TAP) >= 1% Esophageal Squamous Cell Carcinoma Fluorouracil, Oxaliplatin, Tislelizumab
FDA (1) PD-L1 (TAP) >= 1% Esophageal Squamous Cell Carcinoma Capecitabine, Oxaliplatin, Tislelizumab
FDA (1) PD-L1 (TAP) >= 1% Esophageal Squamous Cell Carcinoma Cisplatin, Paclitaxel, Tislelizumab
FDA (1) PD-L1 (TAP) >= 1% Esophageal Squamous Cell Carcinoma Oxaliplatin, Paclitaxel, Tislelizumab
FDA (1) PD-L1 (CPS) >= 1 Esophageal Squamous Cell Carcinoma Cisplatin, Fluorouracil, Tislelizumab
FDA (1) PD-L1 (CPS) >= 1 Esophageal Squamous Cell Carcinoma Capecitabine, Cisplatin, Tislelizumab
FDA (1) PD-L1 (CPS) >= 1 Esophageal Squamous Cell Carcinoma Fluorouracil, Oxaliplatin, Tislelizumab
FDA (1) PD-L1 (CPS) >= 1 Esophageal Squamous Cell Carcinoma Capecitabine, Oxaliplatin, Tislelizumab
FDA (1) PD-L1 (CPS) >= 1 Esophageal Squamous Cell Carcinoma Cisplatin, Paclitaxel, Tislelizumab
FDA (1) PD-L1 (CPS) >= 1 Esophageal Squamous Cell Carcinoma Oxaliplatin, Paclitaxel, Tislelizumab
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