Posted by Michael Wonder on 15 Dec 2022
Update on US regulatory priority review of Lynparza in combination with abiraterone in metastatic castration-resistant prostate cancer
15 December 2022 - AstraZeneca and MSD today announced that the US FDA has informed AstraZeneca that it will extend the Prescription Drug User Fee Act date by three months to provide further time for a full review of the supplementary new drug application for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of metastatic castration-resistant prostate cancer.
The companies will continue to work with the FDA to facilitate the completion of the agency’s review.
