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
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
(C) 2020 Electronic News Publishing, source