FDA and EMA Accept Regulatory Submissions for Review of Talazoparib for Patients With Germline BRCA-Mutated Metastatic Breast Cancer

June 15, 2018 – The U.S. Food and Drug Administration (FDA) recently accepted for filing and granted Priority Review designation a new drug application for talazoparib. The submission is based on results from the EMBRACA trial, which evaluated talazoparib vs chemotherapy in patients with germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer. The Prescription Drug User Fee Act goal date for a decision by the FDA is in … (leggi tutto)