FDA approval for new combination treatment for acute myeloid leukemia

The U.S. Food and Drug Administration today approved Rydapt (midostaurin) for the treatment of adult patients with newly-diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3, in combination with chemotherapy.

The drug, from Swiss pharma giant Novartis (NOVN: VX), is approved for use with a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay, which is used to detect the FLT3 mutation in patients with AML.

AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of white blood cells in the bloodstream. The National Cancer Institute estimated that approximately 19,930 people would be diagnosed with AML in 2016 and 10,430 were projected to die of the disease.