EU Moves To RATIFY Novartis' Rydapt for AML

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.

Approve
Novartis moves ahead of the competition with Rydapt approval • Source: Shutterstock

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...

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