Regulatory approval
Published by the Food and Drug Administration.
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
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | HER2-negative, PD-L1 (TAP) >= 1% | Adenocarcinoma of the Gastroesophageal Junction | Capecitabine, Oxaliplatin, Tislelizumab | FDA |
| Sensitivity (+) | HER2-negative, PD-L1 (TAP) >= 1% | Adenocarcinoma of the Gastroesophageal Junction | Cisplatin, Fluorouracil, Tislelizumab | FDA |
| Sensitivity (+) | HER2-negative, PD-L1 (CPS) >= 1 | Adenocarcinoma of the Gastroesophageal Junction | Capecitabine, Oxaliplatin, Tislelizumab | FDA |
| Sensitivity (+) | HER2-negative, PD-L1 (CPS) >= 1 | Adenocarcinoma of the Gastroesophageal Junction | Cisplatin, Fluorouracil, Tislelizumab | FDA |