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What type of leukemia is Xospata (gilteritinib) used to treat?

Medically reviewed by Judith Stewart, BPharm. Last updated on March 20, 2023.

Official answer


Xospata (gilteritinib) is an oral treatment used to treat adult patients with relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3).

Xospata is the first and only FLT3-targeted therapy to be approved by the FDA for this patient population. The FLT3 mutation is detected using the FDA-approved LeukoStrat CDx FLT3 Mutation Assay, developed by Invivoscribe Technologies, Inc.

Approximately 25 to 30 percent of patients with acute myeloid leukemia have a FLT3 mutation, and it is associated with a particularly aggressive form of the disease.

Xospata inhibits multiple receptor tyrosine kinases, including FLT3. It has been shown to be effective against two FLT3 mutations, FLT3 internal tandem duplication (ITD) and FLT3 tyrosine kinase domain (TKD).

In April 2017, the FDA approved Rydapt (midostaurin) as the first targeted therapy for FLT3-mutated acute myeloid leukemia. Rydapt is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukemia with the FLT3 mutation, in combination with chemotherapy (cytarabine and daunorubicin).

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