Gilteritinib to treat AML with FLT3 mutationFebruary 5, 2019
Gilteritinib (Xospata) has been granted approval for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation.
The US FDA also approved an expanded indication for LeukoStrat CDx FLT3 Mutation Assay, developed by Invivoscribe Technologies, Inc. and used to detect the FLT3 mutation in patients with AML.
The efficiency of gilteritinib (Xospata) was studied in a clinical trial of 138 patients with relapsed or refractory AML having a confirmed FLT3 mutation.
Twenty-one percent of patients achieved a complete remission or complete remission with partial hematologic recovery with treatment. Of the 106 patients who required red blood cell or platelet transfusions at the start of treatment with gilteritinib, 31 percent became transfusion-free for at least 56 days.
The FDA granted this application Fast Track and Priority Review designation. Gilteritinib also received Orphan Drug designation. Xospata is marketed by Astellas Pharma.