FDA accepts NDA for talazoparib for patients with germline (inherited) BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer.- Pfizer.

Pfizer Inc. announced the FDA 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 (inherited) BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer.

The PDUFA goal date for a decision by the FDA is in December 2018. The European Medicines Agency has also accepted the Marketing Authorization Application for talazoparib in the patient population.

In the Phase III EMBRACA trial in patients with germline (inherited) BRCA1/2-positive (gBRCA+) locally advanced and/or metastatic breast cancer (MBC)there was demonstrated superior progression-free survival (PFS) in patients treated with talazoparib, compared to patients who received physician’s choice standard of care chemotherapy. Median PFS was 8.6 months (95% CI: 7.2, 9.3) for patients treated with talazoparib and 5.6 months (95% CI: 4.2, 6.7) for those treated with chemotherapy [HR: 0.54 (95% CI: 0.41, 0.71), p<0.0001]. This represents a 46% reduction in the risk of disease progression. In addition, the proportion of patients achieving a complete or partial response (objective response rate) in the talazoparib group was more than twice that of the control arm (62.6% for talazoparib vs. 27.2% for chemotherapy [OR: 4.99 (95% CI: 2.9-8.8), p<0.0001]).