KENILWORTH - 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.

The regulatory submission is based on the results from the pivotal Phase 3 PAOLA-1 trial, which were published in The New England Journal of Medicine. The trial compared LYNPARZA when added to standard-of-care (SoC) bevacizumab versus bevacizumab alone in women with advanced ovarian cancer in the first-line maintenance setting, regardless of their genetic biomarker status or outcome from previous surgery.

The investigator-assessed results showed LYNPARZA added to bevacizumab reduced the risk of disease progression or death by 41% and improved progression-free survival to a median of 22.1 months versus 16.6 months for patients treated with bevacizumab alone (HR 0.59 [95% CI, 0.49-0.72], p

(C) 2020 Electronic News Publishing, source ENP Newswire