Regulatory approval

Published by the Health Service Executive. Approved

Pembrolizumab is indicated, in combination with CARBOplatin and 5-Fluorouracil, for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS >= 1.

This is written in the approval document.

Reimbursement

Incomplete Reimbursement

Pembrolizumab - ODMS; Carboplatin, 5-Fluorouracil - N/A

Citation

Pembrolizumab, CARBOplatin (AUC 5) and 5-Fluorouracil Therapy, 2025, version number 2d, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6881/705_V2d_Pembrolizumab_CARBOplatin_5FU.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	PD-L1 (CPS) >= 1	Head and Neck Squamous Cell Carcinoma	Carboplatin, Fluorouracil, Pembrolizumab