Therapeutic Response

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

Statements

Source and description
Talazoparib Therapy. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved talazoparib for reimbursement as a monotherapy treatment option 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 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 prior endocrine-based therapy or be considered unsuitable for endocrine-based therapy.
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.