Benzinga | Nov 30, 2021 04:42PM EST

AstraZeneca And Merck Announce FDA Has Accepted Submission Of Supplemental New Drug Application For LYNPARZA

AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that a supplemental New Drug Application (sNDA) for LYNPARZAhas been accepted and granted priority review by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of patients with BRCA-mutated (BRCAm), human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date during the first quarter of 2022.