Therapeutic Response

BRCA2 pathogenic variants and HER2-negative status confers therapeutic sensitivity to Talazoparib in patients with Invasive Breast Carcinoma.

Statements

Source and description
Talzenna (talazoparib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to talazoparib for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. The product label states to select patients for therapy based on an FDA-approved companion diagnostic for Talazoparib.
Talzenna (talazoparib) [product information]. EMA. The European Medicines Agency (EMA) has authorized talazoparib for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endrocrine-based therapy, or be considered unsuitable for endocrine-based therapy.