Regulatory approval
Published by the Health Service Executive. Approved
The Republic of Ireland's Health Service Executive (HSE) has approved nivolumab in combination with fluoropyrimidine and platinum-based combination chemotherapy for reimbursement as a treatment option for the first-line treatment of adult patients with HER-2 negative advanced or metastatic gastric (GC), gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (EAC), whose tumours express PD-L1 (CPS) >= 5. This regimen specifically cites FOLFOX-6 modified therapy as the chemotherapy. It also notes that, as the platinum and fluoropyrimidine based chemotherapy is not defined in the EMA licensed indication, other evidence-based platinum and fluoropyrimidine regimens may be used in combination with nivolumab.
This is written in the approval document as:
Nivolumab in combination with fluoropyrimidine and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER-2 negative advanced or metastatic gastric (GC), gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (EAC), whose tumours express PD-L1 (CPS) >= 5.
Reimbursement
Incomplete Reimbursement
Nivolumab - ODMS; Oxaliplatin, 5-Flourouracil - N/A
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organizations | Biomarkers | Cancer types | Therapies | |
|---|---|---|---|---|
| HSE (1) | HER2-negative, PD-L1 (CPS) >= 5 | Esophageal Adenocarcinoma | Fluorouracil, Nivolumab, Oxaliplatin | |
| HSE (1) | HER2-negative, PD-L1 (CPS) >= 5 | Adenocarcinoma of the Gastroesophageal Junction | Fluorouracil, Nivolumab, Oxaliplatin | |
| HSE (1) | HER2-negative, PD-L1 (CPS) >= 5 | Stomach Adenocarcinoma | Fluorouracil, Nivolumab, Oxaliplatin |
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2026-08-02 | Van Allen lab | Initial curation of into moalmanac-db |
| 2026-02-01 | Health Service Executive | Indication approved for reimbursement. |