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-containing chemotherapy for the first-line treatment of adult patients unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (>=1). This indication is based on RATIONALE-306 (NCT03783442), a global, randomized, placebo-controlled, double-blind study. PD-L1 status was assessed using an assay that reported Tumor Area Positivity (TAP), though a retrospective scoring of tumor PD-L1 status using Combined Positive Score (CPS) was also conducted. Chemotherapy regimens consisted of tevimbra in combination with either: cisplatin and fluoropyrimidine, cisplatin and capecitabine, oxaliplatin and fluoropyrimidine, oxaplatin and capecitabine, cisplatin and paclitaxel, or oxaliplatin and paclitaxel.

This is written in the approval document as:

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).

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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Therapeutic response

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

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (2) PD-L1 (TAP) >= 1% Esophageal Squamous Cell Carcinoma Cisplatin, Fluorouracil, Tislelizumab
FDA (2) PD-L1 (TAP) >= 1% Esophageal Squamous Cell Carcinoma Capecitabine, Cisplatin, Tislelizumab
FDA (2) PD-L1 (TAP) >= 1% Esophageal Squamous Cell Carcinoma Fluorouracil, Oxaliplatin, Tislelizumab
FDA (2) PD-L1 (TAP) >= 1% Esophageal Squamous Cell Carcinoma Capecitabine, Oxaliplatin, Tislelizumab
FDA (2) PD-L1 (TAP) >= 1% Esophageal Squamous Cell Carcinoma Cisplatin, Paclitaxel, Tislelizumab
FDA (2) PD-L1 (TAP) >= 1% Esophageal Squamous Cell Carcinoma Oxaliplatin, Paclitaxel, Tislelizumab
FDA (2) PD-L1 (CPS) >= 1 Esophageal Squamous Cell Carcinoma Cisplatin, Fluorouracil, Tislelizumab
FDA (2) PD-L1 (CPS) >= 1 Esophageal Squamous Cell Carcinoma Capecitabine, Cisplatin, Tislelizumab
FDA (2) PD-L1 (CPS) >= 1 Esophageal Squamous Cell Carcinoma Fluorouracil, Oxaliplatin, Tislelizumab
FDA (2) PD-L1 (CPS) >= 1 Esophageal Squamous Cell Carcinoma Capecitabine, Oxaliplatin, Tislelizumab
FDA (2) PD-L1 (CPS) >= 1 Esophageal Squamous Cell Carcinoma Cisplatin, Paclitaxel, Tislelizumab
FDA (2) PD-L1 (CPS) >= 1 Esophageal Squamous Cell Carcinoma Oxaliplatin, Paclitaxel, 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.