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News From the Food and Drug Administration
June 6, 2017

New AML Therapy and Diagnostic

JAMA. 2017;317(21):2157. doi:10.1001/jama.2017.6304

A recently approved treatment for acute myeloid leukemia (AML) is intended for use along with a companion diagnostic in patients who also receive chemotherapy.

Midostaurin was approved for patients newly diagnosed with AML who have the fms-like tyrosine kinase 3 (FLT3) mutation, as detected by the LeukoStrat CDx FLT3 Mutation Assay. The drug is not indicated as a single-agent induction therapy for patients with AML. Marketed as Rydapt, the drug also was approved for adults with other rare blood disorders—aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm, and mast cell leukemia.