Regulatory approval

Published by the Health Service Executive.

The Republic of Ireland's Health Service Executive (HSE) has approved pembrolizumab in combination with platinum and fluoropyrimidine-based chemotherapy for for reimbursement as a treatment option for the first-line treatment of adult patients with unresectable or metastatic carcinoma of the oesophagus or HER2-negative gastro-osophageal junction adenocarcinoma whose tumors express PD-L1 with CPS >= 10.

This is written in the approval document as:

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.

Citation

Pembrolizumab and FOLFOX-6 Modified Therapy, 2025, version number 2a, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6440/839_v2a_Pembrolizumab_FOLFOX.pdf

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
HSE (1) HER2-negative, PD-L1 (CPS) >= 10 Adenocarcinoma of the Gastroesophageal Junction Fluorouracil, Oxaliplatin, Pembrolizumab