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FDAnews Drug Daily Bulletin

EC Approves Novartis Cancer Drug

Sept. 27, 2017

The European Commission approved Novartis’ Rydapt (midostaurin) for two cancer indications.

The medicine was approved for adults with newly diagnosed acute myeloid leukemia who are FLT3 mutation-positive, and for adults with aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm or mast cell leukemia.

The approval applies to the 28 European Union countries, plus Iceland, Norway, and Liechtenstein. Rydapt has also received approval in the United States, Switzerland and Canada, for varying indications, the company said.

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