AstraZeneca and Merck announced that the U.S. Food and Drug Administration informed AstraZeneca that the agency will extend by three months the Prescription Drug User Fee Act date for the pending new drug application for Lynparza in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer. (mCRPC).
AstraZeneca and Merck jointly developed Lynparaza, which is used in treating various types of cancer.
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 complete the review.
The decision is based on the Phase 3 PROpel trial, results. The application was granted priority review.
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 for the treatment of adult patients with mCRPC where chemotherapy is not indicated. This combination is also undergoing regulatory reviews in other countries.
Approved indications for Lynpareza are not affected for ovarian and other types of cancer by this review period extension.
Annual sales of the drug were estimated at about $1.8 billion in 2020.
AstraZeneca has manufacturing, logistics and administrative operations in northern Delaware.
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