Regulatory approval

Published by the Health Service Executive.

The Republic of Ireland's Health Service Executive (HSE) has approved atezolizumab 1200mg as a monotherapy for reimbursement as a treatment option for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression >= 50% tumor cells (TC) or >= 10% tumor-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC.

This is written in the approval document as:

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.

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.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
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