Talazoparib Granted Priority Review by FDA for BRCA+ Metastatic Breast Cancer


“A new drug application (NDA) for the PARP inhibitor talazoparib has been granted a priority review by the FDA 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 agent.

“In results from the phase III EMBRACA trial, on which the application is based, talazoparib reduced risk of disease progression or death by 46% compared with chemotherapy in patients with BRCA-positive advanced breast cancer. At a median follow-up of 11.2 months, the Median progression-free survival (PFS) at the median follow-up of 11.2 months was 8.6 months (95% CI, 7.2-9.3) with talazoparib versus 5.6 months (95% CI, 4.2-6.7) with physician’s choice of therapy (HR, 0.54; 95% CI, 0.41-0.71; P <.0001). The objective response rate (ORR) was 62.6% (95% CI, 55.8-69.0) compared with 27.2% (95% CI, 19.3-36.3), respectively (odds ratio, 4.99; 95% CI, 2.9-8.8; 2-sided P value <.0001).”

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