FDA, EMA accept application for talazoparib in metastatic breast cancer with inherited BRCA mutation

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Pfizer Inc. said FDA has accepted for filing and granted Priority Review designation to the company’s New Drug Application for talazoparib. The submission is based on results from the EMBRACA trial, which evaluated talazoparib versus chemotherapy in patients with germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer.

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