- 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.
- 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.
- 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.
- Full results of the ADMIRAL trial are yet to be published.
Prescribing Information, click here .