Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized tislelizumab in combination with platinum-based chemotherapy for the first-line treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (OSCC) whose tumours express PD-L1 with a tumor area positivity (TAP) score >= 5%. This indication is based on BGB-A317-306, a multi-regional, randomized, placebo-controlled, double-blind phase 3 study. The chemotherapy doublet regimen consisted of: cisplatin and 5-FU; cisplatin and capecitabine; oxaliplatin and 5-FU; oxaliplatin and capecitabine; cisplatin and paclitaxel; or oxaliplatin and paclitaxel.
This is written in the approval document as:
Tevimbra, in combination with platinum-based chemotherapy, is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic OSCC whose tumours express PD-L1 with a 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% | Esophageal Squamous Cell Carcinoma | Cisplatin, Fluorouracil, Tislelizumab | |
| Sensitivity (+) | PD-L1 (TAP) >= 5% | Esophageal Squamous Cell Carcinoma | Capecitabine, Cisplatin, Tislelizumab | |
| Sensitivity (+) | PD-L1 (TAP) >= 5% | Esophageal Squamous Cell Carcinoma | Fluorouracil, Oxaliplatin, Tislelizumab | |
| Sensitivity (+) | PD-L1 (TAP) >= 5% | Esophageal Squamous Cell Carcinoma | Capecitabine, Oxaliplatin, Tislelizumab | |
| Sensitivity (+) | PD-L1 (TAP) >= 5% | Esophageal Squamous Cell Carcinoma | Cisplatin, Paclitaxel, Tislelizumab | |
| Sensitivity (+) | PD-L1 (TAP) >= 5% | Esophageal Squamous Cell Carcinoma | Oxaliplatin, Paclitaxel, Tislelizumab |