FDA Accepts Regulatory Submission of Supplemental New Drug Application for LYNPARZA® (olaparib) as First-Line Maintenance with Bevacizumab in Advanced Ovarian Cancer and Grants Priority Review
Submission Based on PAOLA-1 Trial Which Studied LYNPARZA with Bevacizumab in Women Regardless of Their Biomarker Status Who Responded to Platinum-Based Chemotherapy
KENILWORTH, N.J.–(BUSINESS WIRE)–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.
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