Regulatory approval
Published by the Health Canada.
Health Canada approved olaparib for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy.
This is written in the approval document as:
LYNPARZA (olaparib) is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients must have confirmation of a germline BRCA mutation before LYNPARZA treatment is initiated.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | BRCA1 pathogenic variants, HER2-negative | Invasive Breast Carcinoma | Olaparib | |
| Sensitivity (+) | BRCA2 pathogenic variants, HER2-negative | Invasive Breast Carcinoma | Olaparib |