Regulatory approval

Published by the Health Service Executive. Approved

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.

This is written in the approval document.

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