Posted by Michael Wonder on 14 Nov 2016
Novartis drug PKC412 (midostaurin) granted FDA priority review for newly-diagnosed FLT3-mutated AML and advanced systemic mastocytosis
14 November 2016 - The AML treatment strategy has remained unchanged for more than 25 years and PKC412 (midostaurin) may represent first FLT3-mutated AML drug with a survival benefit.
Novartis today announced that the US FDA granted priority review to the PKC412 (midostaurin) new drug application for the treatment of acute myeloid leukemia (AML) in newly-diagnosed adults with an FMS-like tyrosine kinase-3 (FLT3) mutation, as well as for the treatment of advanced systemic mastocytosis. The pre-market approval application for the PKC412 (midostaurin) FLT3 companion diagnostic, developed in collaboration with Invivoscribe Technologies has also been accepted for review by the FDA.
Outside the US, the marketing authorisation application for PKC412 (midostaurin) in these indications has already been accepted by the EMA.
