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EU Approves Midostaurin for AML, Advanced Systemic Mastocytosis

Jason Harris
Published: Wednesday, Sep 20, 2017

Bruno Strigini, CEO

Bruno Strigini, CEO
The European Commission has approved midostaurin (Rydapt) for adults with newly diagnosed FLT3-positive acute myeloid leukemia (AML) and advanced systemic mastocytosis (SM), including aggressive systemic mastocytosis (SM), SM with associated hematological neoplasm (SM-AHN), and mast cell leukemia.

Of the 116 patients in the intention-to-treat population, 84 (72%) discontinued treatment and 32 (28%) were receiving ongoing treatment at the time of data cutoff.


  1. Stone RM, Mandrekar SJ, Sanford BL, et al. Midostaurin plus Chemotherapy for Acute Myeloid Leukemia with a FLT3 Mutation. N Engl J Med. 2017;377(5):454-464.
  2. Gotlib J, Kluin-Nelemans HC, George TI, et al. Efficacy and Safety of Midostaurin in Advanced Systemic Mastocytosis. N Engl J Med. 2016; 374(26):2530-2541.

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