In 2016, the pediatric development program for Gilteritinib started, and in 2018, EMA approved several modifications to the pediatric investigation plan that now include two clinical studies evaluating Gilteritinib used in sequential combination with chemotherapy in pediatric patients from 6 months to <18 years of age with FLT3-ITD positive relapse/refractory AML (2215-CL-0603) or newly diagnosed AML (2215-CL-0604). This evidence concerns the gene FLT3 and acute myeloid leukemia.