Regulatory approval
Published by the Health Canada.
Health Canada approved pembrolizumab, in combination with chemotherapy, for the treatment of adult patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC), who have not received prior chemotherapy for metastatic disease and whose tumours express PD-L1 (Combined Positive Score [CPS] ≥ 10) as determined by a validated test.
This is written in the approval document as:
KEYTRUDA (pembrolizumab), in combination with chemotherapy, is indicated for the treatment of adult patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC), who have not received prior chemotherapy for metastatic disease and whose tumours express PD-L1 (Combined Positive Score [CPS] ≥ 10) 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 (+) | ER negative, HER2-negative, PD-L1 (CPS) >= 10, PR negative | Invasive Breast Carcinoma | Paclitaxel, Pembrolizumab |