Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BRCA1 pathogenic variants, HER2-negative status confers therapeutic sensitivity to Talazoparib in patients with Invasive Breast Carcinoma.
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.
This statement is based on a regulatory approval from the Health Service Executive:
Talazoparib is indicated as 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 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 endocrine-based therapy or be considered unsuitable for endocrine-based therapy.