FDA Approves Lynparza Combination for Certain Metastatic Prostate Cancer

June 5, 2023

The FDA has approved AstraZeneca and Merck’s Lynparza, in combination with abiraterone and prednisone or prednisolone, for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).

In the U.S., prostate cancer is the second most common cancer in men, and despite an increase in the number of available therapies for patients with mCRPC, five-year survival remains low, the company said. Approximately 10 percent of patients with mCRPC will have BRCA mutations, which are associated with a poor prognosis and worse outcomes.

The approval was based on phase 3 trial results that showed Lynparza plus abi/pred demonstrated clinically meaningful improvements in both radiographic progression-free survival and overall survival versus abi/pred alone in patients with BRCAm mCRPC.

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