Regulatory approval

Published by the Health Canada. Approved

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.

This is written in the approval document.

Citation

AstraZeneca Canada Inc. Lynparza (olaparib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00080849.PDF. Published June 2025. Accessed April 2026.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
HC (1) BRCA1 pathogenic variants, HER2-negative Invasive Breast Carcinoma Olaparib
HC (1) BRCA2 pathogenic variants, HER2-negative Invasive Breast Carcinoma Olaparib

Contributions

Date Contributor Description
2024-10-30 Van Allen lab Initial access of FDA approvals