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Novartis' NDA for PKC412 granted Priority Review in U.S. for AML and mastocytosis

Published 11/14/2016, 10:02 AM
Novartis' NDA for PKC412 granted Priority Review in U.S. for AML and mastocytosis
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  • The FDA accepts under Priority Review Novartis' (NVS -2.2%) New Drug Application (NDA) seeking approval of Breakthrough Therapy-tagged PKC412 (midostaurin) for the treatment of acute myeloid leukemia (AML) in newly diagnosed adults with a genetic mutation called FMS-like tyrosine kinase-3 (FLT3) and for the treatment of advanced systemic mastocytosis (SM).
  • The late-stage data supporting the filing was generated in the RATIFY study which showed treatment with PKC412 plus standard chemo in FLT3-positive AML patients significantly extended overall survival compared to placebo plus chemo with 23% less risk of death (hazard ratio = 0.77; p=0.0074).
  • Data from a Phase 2 study in SM showed a 60% response rate in the PKC412 cohort with a median duration of response of 24.1 months.
  • The company's marketing application in Europe for these two indications is currently under review.
  • Priority Review status shortens the review clock to six months from the standard 10 months.
  • PKC412 (midostaurin) is an oral, multi-targeted kinase inhibitor. Kinases help regulate many essential cell processes so interfering with their activity interrupts the ability of cancer cells to grow and multiply.

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