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

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 December 2018. The European Medicines Agency (EMA) 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, MD, Chief Development Officer, Oncology, Pfizer Global Product Development.  

Talazoparib is an investigational, once-daily, oral poly ADP ribose polymerase (PARP) inhibitor. The EMBRACA trial evaluated once-daily talazoparib compared to physician’s choice of chemotherapy (capecitibine, eribulin [Halaven], gemcitabine, or vinorelbine) in 431 patients with an inherited BRCA1/2 mutation and locally advanced or metastatic triple-negative or hormone receptor–positive/HER2-negative breast cancer.

The study met its primary endpoint, demonstrating superior progression-free survival with talazoparib vs chemotherapy. The progression-free survival benefit was consistent across prespecified subgroups, including those who had a history of brain metastases, patients previously treated with chemotherapy, patients with triple-negative disease, and those with hormone receptor–positive disease. Grade 3 adverse reactions with talazoparib that occurred with a frequency of at least 10% were anemia (35%), neutropenia (17%), and thrombocytopenia (17%).

The primary results were presented at the 2017 San Antonio Breast Cancer Symposium. 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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