Regulatory approval
Published by the Health Canada.
Health Canada approved pembrolizumab for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) as monotherapy, in adult patients whose tumours have PD-L1 expression (Combined Positive Score [CPS] ≥ 1) as determined by a validated test.
This is written in the approval document as:
KEYTRUDA (pembrolizumab) is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) as monotherapy, in adult patients whose tumours have PD-L1 expression (Combined Positive Score [CPS] ≥ 1) as determined by a validated test.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | PD-L1 (CPS) >= 1 | Head and Neck Squamous Cell Carcinoma | Pembrolizumab |