Xospata approved in Japan to treat AML.- Astellas
Xospata (gilteritinib) has received its first approval globally, in Japan for FLT3 mutation-positive relapsed or refractory acute myeloid leukemia (AML).
Gilteritinib has demonstrated inhibitory activity against both internal tandem duplication (ITD) and tyrosine kinase domain (TKD) FLT3 mutations, and the approval was supported by interim results from the ongoing multinational, 371-patient Phase III ADMIRAL trial, an open-label study of gilteritinib versus salvage chemotherapy in adult patients with FLT3 mutations who are refractory to, or have relapsed after, first-line AML therapy.
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