Regulatory approval

Published by the Health Service Executive. Approved

As monotherapy 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

ODMS

Citation

Pembrolizumab 400mg Monotherapy, 2024, version number 13, NCCP National SACT Regimen, NCCP, viewed 02/08/2026, https://healthservice.hse.ie/documents/6389/558_v12b_Pembrolizumab_400mg_monotherapy.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	Pembrolizumab

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2021-12-20	Health Service Executive	Indication approved for reimbursement.