Rydapt® (midostaurin) – New orphan drug approval
April 28, 2017 – The FDA announced the approval of Novartis’ Rydapt (midostaurin) capsules for the following: in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive, as detected by a FDA approved test; and for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis (SM) with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).
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