What is the role of the gilteritinib (Xospata) for the treatment of relapsed acute myeloid leukemia (AML)?

Updated: May 26, 2020
  • Author: Karen Seiter, MD; Chief Editor: Emmanuel C Besa, MD  more...
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In November 2018, the FDA approved gilteritinib (Xospata), an orally administered multiple tyrosine kinase inhibitor, for treatment of adults with relapsed or refractory AML that has an FLT3 mutation. Gilteritinib inhibits multiple receptor tyrosine kinases, including FMS-like tyrosine kinase 3 (FLT3). It inhibits FLT3 receptor signaling and proliferation in cells exogenously expressing FLT3. Gilteritinib also induces apoptosis in leukemic cells expressing FLT3-ITD.

Approval of gilteritinib was based on interim analysis of the ADMIRAL clinical trial, a phase 3 open-label, multicenter, randomized study comparing gilteritinib with salvage chemotherapy in 371 adults with relapsed or refractory FLT3-mutated AML. Salvage chemotherapy consisted of low-dose cytarabine or azacitidine, MEC (mitoxantrone, etoposide, and intermediate-dose cytarabine), or FLAG-IDA (fludarabine, cytarabine, G-CSF, and idarubicin). Final results of ADMIRAL demonstrated significant superiority of gilteritinib over salvage chemotherapy. Patients randomized to gilteritinib had significantly longer overall survival (9.3 months, versus 5.6 months with salvage chemotherapy; hazard ratio [HR] for death = 0.637; P=0.0007), as well as 1-year survival (37.1% versus 16.7%, respectively). [100]

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