AstraZeneca-Merck's Prostate Cancer Drug Under FDA Priority Review For Expanded Use

The FDA has accepted AstraZeneca Plc’s AZN supplemental marketing application for Lynparza (olaparib) combination regime for metastatic castration-resistant prostate cancer (mCRPC).
Lynparza is being jointly developed and commercialized by AstraZeneca and Merck & Co Inc MRK.
The application covers Lynparza combined with abiraterone and prednisone or prednisolone.
Also Read: Merck & AstraZeneca Partnered Lynparza Fails In Late-Stage Colorectal Cancer Study.
Under the priority review status, the Prescription Drug User Fee Act date is anticipated during the fourth quarter of 2022.
The submission was based on results from the PROpel Phase 3 trial that showed that the Lynparza combo reduced the risk of disease progression or death by 34% versus abiraterone alone.
Median radiographic progression-free survival was 24.8 months for Lynparza plus abiraterone versus 16.6 for abiraterone alone.
Lynparza is approved in the U.S. for HRR gene-mutated mCRPC (BRCA-mutated and other HRR gene mutations) progressed following prior treatment with enzalutamide or abiraterone.
Price Action: AZN shares are down 0.27% at $66.63 during the premarket session on the last check Tuesday.