KENILWORTH - AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that a supplemental New Drug Application (sNDA) for LYNPARZA has been accepted and granted priority review by the U.S. Food and Drug Administration (FDA) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) and deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutations, who have progressed following prior treatment with a new hormonal agent.

A Prescription Drug User Fee Act (PDUFA) date is set for the second quarter of 2020.

The sNDA acceptance for review by the FDA is based on positive results from the Phase 3 PROfound trial, which were presented during a Presidential Symposium at the 2019 European Society of Medical Oncology congress.

Results of the PROfound trial showed LYNPARZA met its primary endpoint, significantly reducing the risk of radiographic disease progression or death by 66% in patients with BRCA1/2 or ATM-mutated mCRPC and improved radiographic progression-free survival (rPFS) to a median of 7.4 months vs. 3.6 months for patients receiving abiraterone or enzalutamide (HR 0.34 [95% CI, 0.25-0.47], p

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