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) [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.
Lynparza (olaparib) [product information]. EMA. The European Medicines Agency (EMA) has authorized olaparib as a monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered sunsuitable for endocrine therapy.
Lynparza (olaparib) [product information]. EMA. The European Medicines Agency (EMA) has authorized olaparib as both a monotherapy and in combination with endocrine for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy. Lynparza's product information cites the OlympiA trial, where olaparib was compared against placebo for the treatment of patients with germline BRCA1/2 mutated and HER2-negative high risk early breast cancer.
Olaparib (Tablet) Monotherapy. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved olaparib (tablet) for reimbursement as a monotherapy or in combination with endocrine therapy as a treatment option for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.