Merck, AstraZeneca: FDA to extend PDUFA date for sNDA for LYNPARZA combo

AstraZeneca (AZN) and Merck (MRK) announced that the U.S. FDA has informed AstraZeneca that the agency will extend by three months the Prescription Drug User Fee Act date for the pending supplemental new drug application for LYNPARZA in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer. The purpose of the extension is to provide further time for the full review of the submission. The companies will continue to work with the FDA to facilitate the completion of the agency’s review. The sNDA for LYNPARZA in combination with abiraterone and prednisone or prednisolone is based on the Phase 3 PROpel trial, results of which were published in NEJM Evidence in June 2022. The application was granted priority review, and AstraZeneca and Merck are committed to working with the FDA to bring this treatment option to patients with mCRPC.