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Novartis gets NOD from European Commission

In a major breakthrough, Novartis announced that the European Commission (EC) approved Rydapt®(midostaurin) for two indications in rare, hard-to-treat cancers.

Rydapt® is indicated for use in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive. The drug also received clearance as monotherapyfor the treatment of adults with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) or mast cell leukemia.

European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on July 20, 2017 approval is applicable for all 28 EU member states. Being first and only targeted therapyfor FMS-like tyrosine kinase 3 (FLT3)-mutated AML, Rydapt® becomes market leader in this class of drug since the last drug entered in more than 25 years.

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