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 PD-L1 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 1680mg Monotherapy - 28 Day, 2020, version number 1, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6399/593_v10a_Atezolizumab_1680mg_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	Atezolizumab
HSE (1)	PD-L1 >= 10% TIIC, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Atezolizumab