Drug updated on 5/17/2024

Dosage FormTablet (oral; 40 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies


  • Indicated for the treatment of refractory or relapsed acute myeloid leukemia in adults with a FLT3 mutation as detected by an FDA-approved test.

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  • Gilteritinib (Xospata) is recommended for adults with relapsed or refractory acute myeloid leukemia characterized by a FLT3 mutation, as detected by an FDA-approved test.
  • Four reviews/meta-analyses were analyzed to collect information on this medication.
  • Gilteritinib displayed superior median survival rates compared to low-dose cytarabine and best supportive care, but not when compared to gemtuzumab ozogamicin.
  • Gilteritinib was associated with higher transplant rates compared to other FLT3 inhibitors and treatments, indicating potential for improved long-term outcomes in some patients.
  • The medication showed advantages across various subgroups of AML patients, including both 'fit' and 'unfit' individuals unable to undergo intensive chemotherapy. It proved superior in inducing complete remission and enhancing survival outcomes in untreated AML as well as in refractory/relapsed FLT3(+)AML subgroups.
  • The safety profile of gilteritinib was regarded as well-tolerated, particularly in comparison with traditional chemotherapy agents. Despite risks associated with thrombocytopenia, neutropenia, anemia, skin and cardiac-related adverse effects, elevated alanine aminotransferase levels, cough, and dyspnea, these were considered manageable compared to the toxicities of traditional chemotherapy.