Dr. Yardley on the FDA Approval of Talazoparib in Breast Cancer

Denise A. Yardley, MD, senior investigator of breast cancer research, Sarah Cannon Research Institute, discusses the FDA approval of talazoparib (Talzenna) for the treatment of patients with germline BRCA mutation—positive, HER2-negative locally advanced or metastatic breast cancer

Talazoparib was approved based on findings from the EMBRACA trial, in which talazoparib reduced the risk of disease progression or death by 46% versus chemotherapy in patients with BRCA-positive advanced breast cancer. This international, open-label study 431 patients with germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer were randomized to receive 1 mg of talazoparib or physician’s choice of chemotherapy, which included capecitabine, eribulin, gemcitabine, or vinorelbine.

The FDA simultaneously approved the BRACAnalysis CDx test to identify patients with breast cancer with deleterious or suspected deleterious germline BRCA-mutated disease who are eligible for talazoparib. This test is developed by Myriad Genetic Laboratories, Inc.