Regulatory approval

Published by the Health Service Executive. Approved

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.

This is written in the approval document.

Reimbursement

ODMS

Citation

Pembrolizumab 200mg Monotherapy, 2026, version number 16, NCCP National SACT Regimen, NCCP, viewed 02/08/2026, https://healthservice.hse.ie/documents/6903/455_V15b__Pembrolizumab_200mg_Monotherapy.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	PD-L1 >= 50%, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Pembrolizumab
HSE (1)	CD274 amplification, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Pembrolizumab

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2018-04-01	Health Service Executive	Indication approved for reimbursement.