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; Cisplatin, 5-Fluorouracil - N/A

Citation

Pembrolizumab 200mg, CISplatin 80mg/m2 and 5-Fluorouracil Infusional Therapy, 2025, version number 2a, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6622/739_v2a_Pembrolizumab200_CISplatin_5-FU.pdf

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	Cisplatin, Fluorouracil, Pembrolizumab
HSE (1)	HER2-negative, PD-L1 (CPS) >= 10	Adenocarcinoma of the Gastroesophageal Junction	Cisplatin, Fluorouracil, Pembrolizumab