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.