Novartis receives positive CHMP opinion for Rydapt® (midostaurin) for newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and three types of advanced systemic mastocytosis (SM)
(WorldNews Switzerland)

Recommendation based on largest trial in FLT3-mutated AML to date, showing 23% reduction in the risk of death with Rydapt treatment regimen[1] If approved, Rydapt would represent the first targeted treatment for newly diagnosed FLT3-mutated AML in the EU Rydapt would be the first and only EMA-approved therapy for advanced SM, a group of rare, life-threatening conditions Basel, July 21, 2017- Novartis today announced that the European Medicines Agency`s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Rydapt (midostaurin) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive....