- 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.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.