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
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) | 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. |