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FDA Grants Talazoparib Priority Review for BRCA+ Breast Cancer

Jason M. Broderick @jasoncology
Published: Thursday, Jun 07, 2018

Dr. Mace Rothenberg

Mace Rothenberg, MD
The FDA has granted a priority review to a new drug application (NDA) for talazoparib for the treatment of patients with germline BRCA mutation–positive, HER2-negative locally advanced or metastatic breast cancer, according to Pfizer, the manufacturer of the PARP inhibitor. 

Among patients with measurable disease, the complete response (CR) rate in the talazoparib arm was 5.5%, the partial response (PR) rate was 57.1%, and the stable disease rate was 21.0%. The corresponding rates in the physician’s choice arm were 0, 27.2%, and 31.6%, respectively. 
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