Regulatory approval
Published by the Health Canada. Approved
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.
This is written in the approval document.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organizations | Biomarkers | Cancer types | Therapies | |
|---|---|---|---|---|
| HC (1) | ER negative, HER2-negative, PD-L1 (CPS) >= 10, PR negative | Invasive Breast Carcinoma | Paclitaxel, Pembrolizumab |