Regulatory approval
Published by the Health Canada.
Health Canada approved cemiplimab as monotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥ 50% of tumour cells (Tumour Proportion Score [TPS] ≥ 50%), as determined by a validated test, with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC.
This is written in the approval document as:
LIBTAYO (cemiplimab for injection) is indicated as monotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥ 50% of tumour cells (Tumour Proportion Score [TPS] ≥ 50%), as determined by a validated test, with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation, or 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 >= 50%, Wild type ALK, Wild type EGFR, Wild type ROS1 | Non-Small Cell Lung Cancer | Cemiplimab | |
| Sensitivity (+) | Wild type ALK, Wild type EGFR, Wild type ROS1 | Non-Small Cell Lung Cancer | Carboplatin, Cemiplimab, Pemetrexed |