US regulators have accepted Pfizer’s filing and granted Priority Review designation to its New Drug Application for talazoparib.
The submission is based on results from the EMBRACA trial, which evaluated talazoparib versus chemotherapy in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer (MBC).
Talazoparib is an investigational, once-daily, oral poly ADP ribose polymerase (PARP) inhibitor.
The European Medicines Agency has also accepted the Marketing Authorization Application for talazoparib in this patient population.
“Women with a hereditary BRCA mutation are typically diagnosed with breast cancer at a younger age than the overall breast cancer population and have limited treatment options when they develop advanced disease,” said Mace Rothenberg, Chief Development Officer, Oncology, Pfizer Global Product Development.
“Today’s filing acceptances are just the latest example of the success of Pfizer’s precision medicine approach to drug development, in this case targeting the faulty DNA damage repair process associated with BRCA mutations.
“We are now one step closer to offering a potential alternative to chemotherapy for these patients.”
The FDA grants Priority Review designation to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in December 2018.