Atezolizumab Monotherapy. NCCP National SACT Regimen. HSE.

Regulatory approval published by the Health Service Executive.

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

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy.	2
Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are considered cisplatin ineligible and whose tumours have a PD-L1 expression >= 5%.	1
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.	2
Adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with non-small cell lung cancer (NSCLC) with a high risk of recurrence whose tumours have PD-L1 expression on >= 50% of tumour cells and who do not have EGFR mutant or ALK-positive mutations.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
HSE (1)	EGFR somatic variants	Non-Small Cell Lung Cancer	Atezolizumab
HSE (1)	v::ALK	Non-Small Cell Lung Cancer	Atezolizumab
HSE (1)	PD-L1 >= 5%	Bladder Urothelial Carcinoma	Atezolizumab
HSE (2)	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