Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved atezolizumab (1680mg) 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 a 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 1680mg Monotherapy - 28 Day, 2024, version number 10a, NCCP National SACT Regimen, NCCP, viewed 04/04/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/lung/593-atezolizumab-1680mg-monotherapy-28-day.pdfTherapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | PD-L1 >= 50%, Wild type ALK, Wild type EGFR | Non-Small Cell Lung Cancer | Atezolizumab | |
| Sensitivity (+) | PD-L1 >= 10% TIIC, Wild type ALK, Wild type EGFR | Non-Small Cell Lung Cancer | Atezolizumab |