Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized tislelizumab in combination with platinum and fluoropyrimidine-based chemotherapy is indicated for the first-line treatment of adult patients with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumors express PD-L1 with a tumor area positivity (TAP) score >= 5%. This indication is based on BGB-A317-305, a global, randomized, double-blind, placebo-controlled study involving 997 patients. The chemotherapy regimen consisted of either oxaliplatin and capecitabine, or cisplatin and 5-FU.
This is written in the approval document as:
Tevimbra, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumours express PD-L1 with a tumour area positivity (TAP) score >= 5%.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | PD-L1 (TAP) >= 5% | Adenocarcinoma of the Gastroesophageal Junction | Capecitabine, Oxaliplatin, Tislelizumab | |
| Sensitivity (+) | PD-L1 (TAP) >= 5% | Adenocarcinoma of the Gastroesophageal Junction | Cisplatin, Fluorouracil, Tislelizumab |