What are the FDA approved medications for FLT3 mutation-positive acute myeloid leukemia (AML)?

Updated: Dec 17, 2018
  • Author: Ari VanderWalde, MD, MPH, MA, FACP; Chief Editor: Karl S Roth, MD  more...
  • Print


In April 2017, the FDA approved midostaurin (Rydapt), a multikinase inhibitor, for adults with newly diagnosed AML who are FLT3 mutation-positive, as detected by an FDA-approved test. The companion test, LeukoStrat CDx FLT3 Mutation Assay, was also approved. Midostaurin in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy experienced a 23% improvement in overall survival (P = 0.0074) compared to those treated with standard induction and consolidation chemotherapy alone. [20]

The FDA approved gilteritinib in November 2018. It is indicated for adults with AML with an FLT3 mutation who have have had a relapse or have been refractory to treatment. FDA approval was based on interim analysis of the ongoing ADMIRAL clinical trial, a phase 3 open-label, multicenter, randomized study comparing gilteritinib with salvage chemotherapy. Salvage chemotherapy consisted of low-dose cytarabine or azacitidine, or MEC (mitoxantrone, etoposide, and intermediate-dose cytarabine) or FLAG-IDA (fludarabine, cytarabine, G-CSF, and idarubicin). [22]

Did this answer your question?
Additional feedback? (Optional)
Thank you for your feedback!