Regulatory approval
Published by the Health Canada.
Health Canada approved nivolumab in combination with ipilimumab, for the treatment of adult patients with metastatic NSCLC, expressing PD-L1 ≥ 1% as determined by a validated test, with no EGFR or ALK genomic tumour aberrations, and no prior systemic therapy for metastatic NSCLC.
This is written in the approval document as:
OPDIVO (nivolumab) in combination with ipilimumab, is indicated for the treatment of adult patients with metastatic NSCLC, expressing PD-L1 ≥ 1% as determined by a validated test, with no EGFR or ALK genomic tumour aberrations, and no prior systemic therapy for metastatic NSCLC.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | PD-L1 >= 1%, Wild type ALK, Wild type EGFR | Non-Small Cell Lung Cancer | Ipilimumab, Nivolumab |