Regulatory approval
Published by the Health Canada.
Health Canada approved atezolizumab as monotherapy, for the first-line treatment of patients with metastatic NSCLC whose tumours have high PD-L1 expression (PD-L1 stained ≥ 50% of TCs or PD-L1 stained tumour-infiltrating immune cells [ICs] covering ≥ 10% of the tumour area), as determined by a validated test and who do not have EGFR or ALK genomic tumour aberrations.
This is written in the approval document as:
TECENTRIQ (atezolizumab, concentrate for solution for infusion) is indicated as monotherapy, for the first-line treatment of patients with metastatic NSCLC whose tumours have high PD-L1 expression (PD-L1 stained ≥ 50% of TCs or PD-L1 stained tumour-infiltrating immune cells [ICs] covering ≥ 10% of the tumour area), as determined by a validated test and who do not have EGFR or ALK genomic tumour aberrations.
Citation
Therapeutic 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 |