Update on US review of Lynparza PROpel sNDA
15 December 2022 07:00 GMT Update on US regulatory priority review of Lynparza in combination withabiraterone 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