Xospata FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 28, 2018.
FDA Approved: Yes (First approved November 28, 2018)
Brand name: Xospata
Generic name: gilteritinib
Dosage form: Tablets
Company: Astellas Pharma US, Inc.
Treatment for: Acute Myeloid Leukemia
Xospata (gilteritinib) is a FLT3/AXL kinase inhibitor indicated for the treatment of patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.
- The efficiency of Xospata was studied in the ADMIRAL trial of 138 patients with relapsed or refractory AML having a confirmed FLT3 mutation. Twenty-one percent of patients achieved 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 Xospata, 31 percent became transfusion-free for at least 56 days.
- Xospata is administered orally, once daily.
- The most common side effects reported in clinical trials were myalgia/arthralgia, transaminase increase, fatigue/malaise, fever, noninfectious diarrhea, dyspnea, edema, rash, pneumonia, nausea, stomatitis, cough, headache, hypotension, dizziness and vomiting.
Development timeline for Xospata
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