Gilteritinib has single-agent activity in FLT3-mutated AML and was approved by the U.S. FDA in November 2018 for treating adult patients who have relapsed or refractory (R/R) FLT3-mutated AML based on safety data and an interim analysis of the response rate in the ADMIRAL trial (NCT02421939) [117]. Here, FLT3 is linked to acute myeloid leukemia.