AstraZeneca and Merck, known as MSD outside the United States and Canada, announced that a supplemental New Drug Application (sNDA) for Lynparza in combination with abiraterone and prednisone or prednisolone has been accepted and granted priority review by the US Food and Drug Administration (FDA) for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date in the fourth quarter of 2022.
In the US, prostate cancer is the second most common cancer in male patients. Approximately 10-20% of male patients with advanced prostate cancer are estimated to develop castration resistant prostate cancer (CRPC) within five years, and at least 84% of these men may develop metastases at the time of CRPC diagnosis. Patients with advanced prostate cancer have a particularly poor prognosis, and the five-year survival rate remains low.
Susan Galbraith, executive vice president, oncology R&D, AstraZeneca, said,
