Update on US regulatory review of Lynparza + abiraterone + prednisone or prednisolone, as treatment of metastatic castration-resistant prostate cancer
AstraZeneca and Merck Inc., announced that the FDA has informed AstraZeneca that the agency will extend by three months the Prescription Drug User Fee Act (PDUFA) date for the pending supplemental new drug application (sNDA) for Lynparza in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC)
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 III PROpel trial, results of which were published in NEJM Evidence in June 2022 (previously cited) 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.
In November, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Lynparza in combination with abiraterone and prednisone or prednisolone in the European Union (EU) for the treatment of adult patients with mCRPC for whom chemotherapy is not clinically indicated. This combination is also undergoing regulatory reviews in other countries.
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