Novartis picks up EU approval for Rydapt

Novartis picks up EU approval for Rydapt
Rydapt capsules. Courtesy of Novartis

The European Commission has approved Novartis’ Rydapt for two indications in rare, hard to treat cancers.

Rydapt is the first and – to date – only therapy for advanced systemic mastocytosis in the European Union.

It is approved for adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive.

The approval follows a positive opinion issued by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in July and applies to all 28 EU member states – plus Iceland, Liechtenstein and Norway.

Rydapt represents the first major advancement for the treatment of patients with newly diagnosed FLT3-mutated AML in more than 25 years.