LeukoStrat CDx FLT3 Mutation Assay, the companion diagnostics test also approved by the US Food and Drug Administration to be used in order to detect FLT3 mutations among patients with acute myeloid leukemia.
FDA approval came about via results based upon phase 3 trials of the study: Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia; ClinicalTrials.gov Identifier: NCT000651261.
Results of the study show a significant overall survival benefit for patients randomly assigned to either receive a placebo or 50 mg of midostaurin twice daily for a year. The double blind study involved 717 participants with newly diagnosed FLT3-positive acute myeloid leukemia. Hazard ratio for the midostaurin group vs placebo group was 0.77(p=.016).
It was noted the observed common adverse events occurring in 20% of patients using midostaurin included nausea, febrile neutropenia, vomiting, mucositis, petechiae, headache, diarrhea, hyperglycemia, musculoskeletal pain, fever, edema, upper respiratory tract infection, device related infection, dyspnea, fatigue, and epistaxis.
Midostaurin must be used in combination with daunorubicin and cytarabine induction, as well as cytarabine consolidation.
