RAHWAY, N.J. - AstraZeneca and Merck (NYSE: MRK), 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 U.S. 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 U.S., 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, 'There remains a critical unmet need among patients diagnosed with mCRPC, where the prognosis remains poor, and treatment options are limited. Today's news is another step towards bringing forward a new, much-needed treatment option in this setting. If approved, LYNPARZA with abiraterone will become the first combination of a PARP inhibitor and a new hormonal agent for patients with this disease.'

Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, 'Merck is committed to developing new treatment options for patients with mCRPC, a complex disease that urgently needs more therapies. We look forward to working with the FDA towards the goal of bringing a new option to patients with mCRPC with or without homologous recombination repair gene mutations.'

The sNDA was based on results from the Phase 3 PROpel trial, which were presented at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium and later published in NEJMEvidence.

In PROpel, LYNPARZA in combination with abiraterone and prednisone or prednisolone reduced the risk of disease progression or death by 34% (HR=0.66 [95% CI, 0.54-0.81]; p

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