PDUFA date extended by three months to review Lynparza + abiraterone and prednisone /prednisolone sNDA for the treatment of mCRPC
US Food and Drug Administration (FDA) 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 pivotal PROpel Phase III trial, which were published in June 2022 in NEJM Evidence.
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