Regulatory approval
Published by the Health Service Executive. Approved
Pembrolizumab in combination with platinum and fluoropyrimidine-based chemotherapy, for the first line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with CPS >= 10.
This is written in the approval document.
Reimbursement
Incomplete Reimbursement
Pembrolizumab - ODMS; Oxaliplatin, 5-Fluorouracil - N/A
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organizations | Biomarkers | Cancer types | Therapies | |
|---|---|---|---|---|
| HSE (1) | PD-L1 (CPS) >= 10 | Esophageal Adenocarcinoma | Dordaviprone | |
| HSE (1) | HER2-negative, PD-L1 (CPS) >= 10 | Adenocarcinoma of the Gastroesophageal Junction | Fluorouracil, Oxaliplatin, Pembrolizumab |