The Food and Drug Administration (FDA) has approved Xospata (gilteritinib; Astellas Pharma) tablets for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. Concurrently, the FDA has expanded the indication for the LeukoStrat CDx FLT3 Mutation Assay (Invivoscribe Technologies, Inc.) for use with Xospata to detect FLT3 mutation in AML patients.
Xospata was evaluated in the Phase 3 open-label, multicenter, randomized ADMIRAL trial (N=138) which included patients with relapsed or refractory AML with a FLT3 ITD, D835, or I836 mutation. Data from an interim analysis showed that 29 patients (21%) who were given Xospata 120mg daily achieved complete remission (CR) or CR with partial hematologic recovery (CRh) after a median follow-up of 4.6 months.
In addition, 33 of 106 patients who were dependent on red blood cell (RBC) and/or platelet transfusions at baseline became transfusion-independent during any 56-day post-baseline period. Of the 32 patients who were independent of both transfusion types at baseline, 17 (53.1%) remained independent during any 56-day post-baseline period. Full data will be submitted for presentation at an upcoming medical meeting.
Myalgia/arthralgia, transaminase increase, fatigue/malaise, fever, noninfectious diarrhea, dyspnea, edema, rash, pneumonia, nausea, stomatitis, cough, headache, hypotension, dizziness, and vomiting were the most common adverse reactions reported.
Xospata will be available as 40mg tablets in 90-count bottles.
For more information call (800) 727-7003 or visit Astellas.com.