Posted by Michael Wonder on 07 Jun 2018
U.S. FDA and EMA accept regulatory submissions for review of tazaloparib for metastatic breast cancer patients with an inherited BRCA mutation
7 June 2018 - U.S. new drug application granted FDA priority review.
Pfizer announced today that the U.S. FDA accepted for filing and granted priority review designation to the company’s new drug application for talazoparib. Talazoparib is an investigational, once-daily, oral poly ADP ribose polymerase (PARP) inhibitor. The European Medicines Agency has also accepted the marketing authorisation application for talazoparib in this patient population.
The pivotal, randomized EMBRACA trial evaluated once-daily talazoparib compared to physician’s choice chemotherapy (capecitibine, eribulin, gemcitabine or vinorelbine) in 431 patients with an inherited BRCA1/2 mutation and locally advanced or metastatic triple negative or hormone receptor-positive/HER2- breast cancer.
