Multicenter phase 1b trial of gilteritinib with induction and consolidation therapy and as maintenance for newly diagnosed AML

The novel type 1 FLT3 inhibitor gilteritinib has single-agent activity for relapsed and refractory AML with FLT3 mutations. A multicenter phase 1b trial in the USA evaluated gilteritinib as part of frontline intensive therapy for AML. The study found that gilteritinib can be safely combined with conventional intensive AML therapy and induces a very high remission rate in patients with FLT3 mutations. Gilteritinib delayed blood count recovery. The median overall survival was 46.1 months.