Cancer News

Gilteritinib Approved for Advanced Acute Myeloid Leukemia (AML) with a FLT3 Mutation

The U.S. Food and Drug Administration approved Xospata (gilteritinib) for treatment of adult patients who have recurrent or refractory acute myeloid leukemia (AML) with a FLT3 mutation.

About Xospata

Xospata has demonstrated inhibitory activity against FLT3 internal tandem duplication (ITD) as well as FLT3 tyrosine kinase domain (TKD), two common types of FLT3 mutations that are seen in approximately one-third of patients with AML.

About Acute Myeloid Leukemia

AML is a cancer that impacts the blood and bone marrow and is most commonly experienced in older adults. According to the American Cancer Society in 2018 there were approximately 22,000 new patients diagnosed with AML in the United States. Mutations of FLT3 in AML are associated with a poor prognosis and the FDA has prioritized the approval of new therapies for FLT3+ AML patients.

The FDA approval of Xospata was based on an interim analysis of the ADMIRAL clinical trial which included 138 adult patients with relapsed or refractory AML and a FLT3 ITD, D835, or I836 mutation. All individuals were treated with oral Xospata daily until unacceptable toxicity or lack of clinical benefit. After a median follow-up of 4.6 months 29 patients had achieved a complete remission.

Among the 106 patients who were dependent on red blood cell (RBC) and/or platelet transfusions 31.1% became independent of RBC and platelet transfusions.  The most common adverse reactions occurring in ≥ 20% of patients were myalgia/arthralgia, transaminase increase, fatigue/malaise, fever, noninfectious diarrhea, dyspnea, edema, rash, pneumonia, nausea, stomatitis, cough, headache, hypotension, dizziness and vomiting.


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