EU Moves To RATIFY Novartis' Rydapt for AML

20 Sep 2017

Rydapt represents the first major development in targeted acute myeloid leukaemia treatment in more than 25 years as Novartis plots its commercial launch in Europe.

Novartis AG is looking at a small but potentially lucrative market after Rydapt (midostaurin) became the first targeted treatment to be approved in Europe for newly-diagnosed FLT3-mutated acute myeloid leukemia (AML) and the only therapy given the green light for three types of advanced systemic mastocytosis (SM).

The road to approval on this side of the Atlantic has had a few bumps in it. The European Medicines Agency’s key advisory committee, the CHMP, issued a positive opinion...

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