Posted by Michael Wonder on 21 Jul 2017
Novartis receives positive CHMP opinion for Rydapt (midostaurin) for newly diagnosed FLT3 mutated acute myeloid leukaemia and three types of advanced systemic mastocytosis
21 July 2017 - Recommendation based on largest trial in FLT3 mutated acute myeloid leukaemia to date, showing 23% reduction in the risk of death with Rydapt treatment regimen.
Novartis today announced that the EMA's CHMP adopted a positive opinion recommending approval of Rydapt (midostaurin) for the treatment of adults with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive. If approved by the European Commission, Rydapt will be indicated 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 adult patients with newly diagnosed AML who are FLT3 mutation-positive.
Rydapt was also recommended for approval as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm or mast cell leukaemia.
