Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that BRCA2 pathogenic variants and HER2-negative status confers therapeutic sensitivity to Talazoparib in patients with Invasive Breast Carcinoma.
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.
This statement is based on a regulatory approval from the European Medicines Agency:
Talzenna 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.
Citation
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2024-10-20 | Van Allen lab | Adding EMA approvals for use to database |
| 2019-06-20 | European Medicines Agency | Indication received approval from the European Commission. |