Regulatory approval

Published by the Health Service Executive. Approved

Pembrolizumab is indicated, in combination with CISplatin 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; Cisplatin, 5-Fluorouracil - N/A

Citation

Pembrolizumab, Cisplatin and 5-Fluorouracil Therapy, 2024, version number 3, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6880/706_V3_Pembrolizumab_CISplatin_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	Cisplatin, Fluorouracil, Pembrolizumab