Regulatory approval

Published by the Health Service Executive.

The Republic of Ireland's Health Service Executive (HSE) has approved pembrolizumab (200mg and 400mg) for reimbursement as a first-line treatment option for the treatment of adult patients with metastatic non-small cell lung carcinoma (NSCLC) whose tumors express PD-L1 with a >= 50% tumor proportion score (TPS) with no EGFR mutations or ALK translocations.

This is written in the approval document as:

First-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a >= 50% tumour proportion score (TPS) with no EGFR mutations or ALK translocations.

Citation

Pembrolizumab 200mg Monotherapy, 2023, version number 13, NCCP National SACT Regimen, NCCP, viewed 18/01/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/gastrointestinal/pembrolizumab-200mg-monotherapy-455.pdf

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	PD-L1 >= 50%, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Pembrolizumab
Sensitivity (+)	CD274 amplification, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Pembrolizumab