Regulatory approval

Published by the Health Service Executive. Approved

As monotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PDL1 expression >= 50% tumour cells (TC) or >= 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC.

This is written in the approval document.

Reimbursement

ODMS

Citation

Atezolizumab 840mg Monotherapy - 14 Day, 2025, version number 3, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6398/592_v3_Atezolizumab_840mg_Monotherapy_14_Day.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	Atezolizumab
HSE (1)	PD-L1 >= 10% TIIC, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Atezolizumab