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In the context of Gilteritinib & Acute Myeloid leukemia (AML) (FLT3 m), the U.S. FDA approved gilteritinib on 28 November 2018 for adults with relapsed or refractory Acute Myeloid leukemia (AML) (FLT3 m), detected by an FDA‑approved test (2, 3, 4). The indication is disease‑ and mutation‑specific: adult R/R AML, FLT3‑mutated (ITD or TKD) (2, 4).
The EMA has likewise approved gilteritinib for adult patients with relapsed or refractory Acute Myeloid leukemia (AML) (FLT3 m). European guidance on R/R AML lists gilteritinib as a standard targeted optio…