FDA to review FLT3 agent for refractory AML


The Food and Drug Administration has granted priority review to an FMS-like tyrosine kinase 3 (FLT3)–targeting agent for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML).

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Astellas Pharma is seeking approval for gilteritinib (ASP2215) for adults with FLT3 mutation–positive AML. If approved, it would be the first FLT3 inhibitor available for this indication.

The application is based on the ongoing ADMIRAL trial, a phase 3, open-label, randomized study of gilteritinib versus salvage chemotherapy. The trial is designed to enroll 369 patients with FLT3 mutations present in bone marrow or whole blood who are refractory or have relapsed on first-line therapy. The primary endpoints are overall survival and rates of complete remission and complete remission with partial hematologic recovery.

The FDA has set Nov. 29 as a target date for reaching a decision on approval of the drug.

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