Regulatory approval

Published by the Health Service Executive.

The Republic of Ireland's Health Service Executive (HSE) has approved pembrolizumab in combination with carboplatin and 5-fluorouracil for reimbursement as a treatment option for the first-line treatment of adult patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 with a CPS >= 1.

This is written in the approval document as:

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.

Citation

Pembrolizumab, CARBOplatin (AUC 5) and 5-Fluorouracil Therapy, 2023, version number 2a, NCCP National SACT Regimen, NCCP, viewed 04/04/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/headandneck/705-pembrolizumab-carboplatin-and-5-fu-therapy.pdf

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	PD-L1 (CPS) >= 1	Head and Neck Squamous Cell Carcinoma	Carboplatin, Fluorouracil, Pembrolizumab