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

ODMS; 2021-10-01 (IV); 2024-06-01 (SC)

Citation

Atezolizumab Monotherapy, 2025, version number 14, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6644/544_v14_Atezolizumab_21_Day_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

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2021-10-01	Health Service Executive	Indication approved for reimbursement.