FDA approves gilteritinib for FLT3+ AML


  • David Reilly
  • Oncology drug update
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Takeaway

  • The FDA has approved gilteritinib for the treatment of adult patients with relapsed/refractory acute myeloid leukemia (R/R AML) with an FLT3 mutation, as detected by the LeukoStrat CDx FLT3 Mutation Assay, a companion diagnostic.

Why this matters

  • Approximately 25%-30% of patients with AML harbor an FLT3 mutation, which is associated with increased risk for relapse.

Study design

  • The approval was based on interim results of the phase 3 ADMIRAL study in 138 patients with R/R AML, and confirmed FLT3 mutation.
  • Funding: Astellas Pharma.

Key results

  • 21% of patients achieved complete remission or complete remission with partial hematologic recovery.
  • Among 106 patients who were red blood cell-dependent or platelet transfusion-dependent at study start, 31% achieved transfusion independence for ≥56 days.
  • Common adverse events observed in clinical trials of gilteritinib included myalgia, arthralgia, fatigue, and elevated liver transaminases.
  • Patients receiving gilteritinib should be monitored for posterior reversible encephalopathy syndrome, prolonged QT interval, and pancreatitis.

Limitations

  • Full results of the ADMIRAL trial are yet to be published.

Prescribing Information, click  here .