Novartis: EU regulator backs rare blood diseases drug.

(CercleFinance.com) - Europe's drugs regulator gave its backing for marketing approval to be granted for Novartis' Rydapt for newly diagnosed FLT3-mutated acute myeloid leukaemia and three types of advanced systemic mastocytosis.


If approved, Rydapt will be the first targeted treatment available in the European Union for newly diagnosed FLT3 mutation-positive acute myeloid leukaemia patients and advanced systemic mastocytosis patients.

Advanced systemic mastocytosis is a rare and aggressive cancer of the blood and bone marrow. Advanced systemic mastocytosis is a rare blood disorder characterised by uncontrolled growth and accumulation of mast cells—the mediators of allergic responses.

The opinion follows a recent US FDA approval of Rydapt in April.

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