Posted by Michael Wonder on 29 Apr 2017
Novartis receives FDA approval for Rydapt in newly diagnosed FLT3-mutated acute myeloid leukaemia and three types of systemic mastocytosis
28 April 2017 - Rydapt treatment regimen in FLT3-mutated AML demonstrated a significant improvement in overall survival with a 23% reduction in the risk of death.
Novartis announced today the US FDA has approved Rydapt (midostaurin, formerly PKC412) for two indications. The first indication is for the treatment of acute myeloid leukemia (AML) in newly diagnosed patients who are FMS-like tyrosine kinase 3 mutation-positive (FLT3+), as detected by an FDA-approved test, in combination with chemotherapy.
Rydapt is also approved to treat adults with advanced systemic mastocytosis (SM), which includes aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) and mast cell leukaemia. This approval follows a prior breakthrough therapy designation in FLT3-mutated AML, as well as orphan drug designation and priority review in both indications by the FDA.
Worldwide filings for Rydapt are currently underway.
