FDA Grants Priority Review to Talazoparib for Metastatic Breast Cancer With BRCA Mutation
Posted: Monday, June 18, 2018
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review designation to Pfizer’s new drug application for talazoparib, an investigational, once-daily, oral PARP inhibitor. The European Medicines Agency has also accepted the marketing authorization application for talazoparib in this patient population.
The submission is based on results from the randomized phase III EMBRACA trial, which compared talazoparib with physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine) in 431 patients with an inherited BRCA1/2 mutation and locally advanced or metastatic triple-negative breast cancer or hormone receptor–positive/HER2-negative breast cancer.
The study met its primary endpoint, demonstrating superior progression-free survival with talazoparib versus 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 breast cancer, and those with hormone receptor–positive disease. The most common adverse reactions with talazoparib were anemia (35%), neutropenia (17%), and thrombocytopenia (17%). The primary results were presented at the 2017 San Antonio Breast Cancer Symposium (Abstract GS6-07).