Posted by Michael Wonder on 20 Sep 2017
Novartis drug Rydapt (midostaurin) receives EU approval for newly diagnosed FLT3-mutated acute myeloid leukaemia and three types of advanced systemic mastocytosis
20 September 2017 - Approval based on data from largest landmark trials in AML and advanced SM to date; first major development in targeted AML treatment in more than 25 years.
Novartis today announced that the European Commission approved Rydapt (midostaurin) for two indications in rare, hard-to-treat cancers. Rydapt is approved 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 leukaemia (AML) who are FLT3 mutation-positive.
It was also cleared for use as monotherapy for the treatment of adults with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) or mast cell leukaemia.
