Novartis Secures Positive EU Committee Opinion on Rydapt

Swiss drug maker Novartis AG said Friday morning that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion and recommended approval of Rydapt for treating adults with newly-diagnosed acute myeloid leukemia who are FLT3 mutation-positive. If approved by the European Commission, the oral, multi-targeted inhibitor of multiple kinases would represent the first targeted treatment for newly diagnosed FLT-3 mutated AML in the EU.

The treatment was also recommended for approval as monotherapy for adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis (SM) with associated hematological neoplasm, or mast cell leukemia, the company noted. CHMP’s positive opinion follows recent approval by the U.S. Food and Drug Administration of Rydapt for FLT3-mutated AML and advanced SM on April 28 and Swissmedica approval on May 4.

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