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Patients with FMS-like tyrosine kinase 3 gene (FLT3)-mutated acute myeloid leukemia (AML) have high rates of induction failure and poor outcomes following cytotoxic chemotherapy in the relapsed or refractory disease setting.
Now, investigators have conducted an industry-sponsored, multicenter, randomized, phase III trial to assess the potential benefit of gilteritinib — an inhibitor of FLT3 and of AXL, a tyrosine kinase implicated in FLT3 inhibitor resistance — in 371 patients with relapsed or refractory FLT3-mutated AML. Patients were assigned 2:1 to receive gilteritinib or salvage chemotherapy. The primary endpoints were overall survival (OS) and complete remission rate (CRR).
Median OS was significantly improved with gilteritinib versus ch…