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 as a treatment option for the first-line treatment of adult patients with HER-2 negative advanced or metastatic gastric cancer (GC), gastroesophageal junction cancer (GEJC), or esophageal adenocarcinoma (EAC), whose tumours express PD-L1 (CPS) >= 5. This treatment regimen is specifically for nivolumab and XELOX (capecitabine and oxaliplatin) therapy, though the treatment regimen specifically notes that other evidence based platinum and fluoropyrimidine based regimens may be used as the EMA licensed indication does not define the platinum and fluoropyrimidine based chemotherapy.

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 cancer (GC), gastroesophageal junction cancer (GEJC), or esophageal adenocarcinoma (EAC), whose tumours express PD-L1 (CPS) >= 5.

Reimbursement

Incomplete Reimbursement

Obinutuzumab - ODMS 2026-02-01; capecitabine and oxaliplatin - N/A

Citation

Nivolumab and XELOX Therapy, 2026, version number 2a, NCCP National SACT Regimen, NCCP, viewed 02/08/2026, https://healthservice.hse.ie/documents/6444/843_Nivolumab_and_XELOX.pdf

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	Stomach Adenocarcinoma	Capecitabine, Nivolumab, Oxaliplatin
HSE (1)	HER2-negative, PD-L1 (CPS) >= 5	Adenocarcinoma of the Gastroesophageal Junction	Capecitabine, Nivolumab, Oxaliplatin
HSE (1)	HER2-negative, PD-L1 (CPS) >= 5	Esophageal Adenocarcinoma	Capecitabine, 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.