Gilteritinib was approved as single-agent therapy for patients with FLT3-mutated R/R AML based on findings from the phase 3 ADMIRAL trial (NCT02421939), which evaluated the safety and efficacy of a daily dose of 120-mg gilteritinib against SC in this patient population [24, 28]. This evidence concerns the gene FLT3 and acute myeloid leukemia.