Regulatory approval
Published by the Health Canada.
Health Canada approved talazoparib as a monotherapy for the treatment of adult patients with a deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated human epidermal growth factor receptor 2 (HER2)-negative locally advanced (not amenable to curative radiation or surgery) or metastatic breast cancer, who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting, unless patients were inappropriate for these treatments.
This is written in the approval document as:
TALZENNA (talazoparib) is indicated as a monotherapy for the treatment of adult patients with a deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated human epidermal growth factor receptor 2 (HER2)-negative locally advanced (not amenable to curative radiation or surgery) or metastatic breast cancer, who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting, unless patients were inappropriate for these treatments.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organization(s) | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| HC (1) | BRCA1 pathogenic variants, HER2-negative | Invasive Breast Carcinoma | Talazoparib | |
| HC (1) | BRCA2 pathogenic variants, HER2-negative | Invasive Breast Carcinoma | Talazoparib |