Priority Review for Novartis' midostaurin

Novartis AG (NYSE:NVS; SIX:NOVN) said FDA accepted and granted Priority Review to an NDA for midostaurin (PKC412; CGP 41251) to treat newly diagnosed FLT3 mutation-positive acute myelogenous leukemia (AML) as well as advanced systemic mastocytosis. The company is not disclosing the PDUFA date.

Novartis also said EMA accepted for review an MAA for to treat the same indications...