Is Talazoparib Approved?

Talazoparib (Talazoparib was first approved for marketing by the U.S. Food and Drug Administration (FDA) in October 2018 under the trade name Talzenna, and was approved by the European Medicines Agency (EMA) in June 2019. Talazopanib is currently indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. It can also be used in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer who have homologous recombination repair (HRR) gene mutations. The original drug of talazopanib has not yet been marketed in the country, so it has not been included in medical insurance.