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AstraZeneca, Merck: FDA accepts sNDA for LYNPARZA.

AstraZeneca (AZN) and Merck (MRK) announced that the U.S. FDA has accepted a supplemental New Drug Application for priority review for the approval of LYNPARZA tablets as a maintenance treatment in patients with newly-diagnosed, BRCA-mutated advanced ovarian cancer who were in complete or partial response following first-line standard platinum-based chemotherapy. A Prescription Drug User Fee Act date is set for the first quarter of 2019. This is the first U.S. regulatory submission acceptance for a poly ADP-ribose polymerase inhibitor in the first-line maintenance setting for advanced ovarian cancer, and, if approved, will be the fourth indication for LYNPARZA in the U.S.

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Publication:The Fly
Date:Nov 12, 2018
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