Update on US regulatory priority review of Lynparza in combination with abiraterone in metastatic castration-resistant prostate cancer
AstraZeneca and MSD today announced that the US Food and Drug Administration (FDA) has informed AstraZeneca that it will extend the Prescription Drug User Fee Act (PDUFA) date by three months to provide further time for a full review of the supplementary new drug application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The companies will continue to work with the FDA to facilitate the completion of the agency’s review. The sNDA is based on results from the