FDA approves Astellas Pharma’s Xospata in AML treatment

Astellas Pharma announced that the FDA approved XOSPATA, or gilteritinib, for the treatment of adult patients who have relapsed or refractory Acute Myeloid Leukemia with a FLT3 mutation as detected by an FDA-approved test. XOSPATA is an oral therapy and the first and only FLT3-targeting therapy to be approved by the FDA for this population. The American Cancer Society estimates that in 2018, approximately 19,000 people will be diagnosed with AML in the U.S. XOSPATA has demonstrated inhibitory activity against two different mutations, FLT3 internal tandem duplication and FLT3 tyrosine kinase domain. Impacting approximately 30% of AML patients, the FLT3-ITD mutation is associated with worsened disease free survival and overall survival. FLT3-TKD mutations impact approximately 7% of AML patients4 and, although the impact of these mutations is less clear, they have been associated with treatment resistance. Previously, XOSPATA was granted both Orphan Drug designation and Fast Track designation by the U.S. FDA. Gilteritinib also received Orphan Designation from the European Commission and Orphan Drug Designation from the Japan Ministry of Health, Labor and Welfare.

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