Therapeutic Response

BRCA1 pathogenic variants and HER2-negative status confers therapeutic sensitivity to Olaparib in patients with Invasive Breast Carcinoma.

Statements

Source and description
Lynparza (olaparib) [product monograph]. HC.

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.
Lynparza (olaparib) [product monograph]. HC.

Health Canada approved olaparib as monotherapy for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2- negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have progressed on or be considered inappropriate for endocrine therapy.
Lynparza (olaparib) [package insert]. FDA.

The U.S. Food and Drug Administration granted approval to olaparib for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Olaparib's product label specifies to select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.
Lynparza (olaparib) [package insert]. FDA.

The U.S. Food and Drug Administration granted approval to olaparib for the treatment of adult patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Olaparib's product label states that patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. The product label also states to select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.