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AstraZeneca and Merck's Supplemental New Drug Application for LYNPARZA Granted Priority Review by the FDA

AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that a supplemental New Drug Application (sNDA) for LYNPARZA in combination with bevacizumab has been accepted and

Benzinga · 01/13/2020 12:46

AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that a supplemental New Drug Application (sNDA) for LYNPARZA in combination with bevacizumab has been accepted and granted priority review by the U.S. Food and Drug Administration (FDA) for the maintenance treatment of women with advanced ovarian cancer whose disease showed a complete or partial response to first-line treatment with platinum-based chemotherapy and bevacizumab.

A Prescription Drug User Fee Act (PDUFA) date is set for the second quarter of 2020.