AstraZeneca PLC (LSE:AZN), and its US peer Merck & Co have announced that the US Food and Drug Administration (FDA) will allow more time to review the new drug application for its cancer drug, Lynparza.
The pharmaceuticals giant said the FDA 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 for Lynparza 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, AstraZeneca said in a statement.
The new drug application is based on results from the pivotal PROpel Phase III trial, which were published in June 2022 in NEJM Evidence.
In August 2022, 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 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.