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FDA Approves Addition of Survival Data to Gilteritinib Label for Refractory FLT3-Mutated AML

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On May 29, the U.S. Food and Drug Administration (FDA) approved the addition of overall survival data in the labeling for gilteritinib (Xospata), which is indicated for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation as detected by an FDA-approved test.

ADMIRAL Trial

Approval was based on the ADMIRAL trial, which included 371 adult patients with relapsed or refractory AML having an FLT3 ITD, D835, or I836 mutation detected by the LeukoStrat® CDx FLT3 Mutation Assay. Patients were randomly assigned 2:1 to receive 120 mg of gilteritinib once daily (n = 247) over continuous 28-day cycles, or prespecified salvage chemotherapy (n = 124). Salvage chemotherapy included either intensive cytotoxic chemotherapy or a low-intensity regimen.

For the analysis, overall survival was measured from the randomization date until death by any cause. The median overall survival was 9.3 months for patients receiving gilteritinib and 5.6 months for those on the chemotherapy arm (hazard ratio [HR] = 0.64; 95% confidence interval [CI] = 0.49–0.83; 1 sided P value = .0004). The results were consistent in the intensive chemotherapy stratum (HR = 0.66; 95% CI = 0.47–0.93) and the low-intensity regimen stratum (HR = 0.56; 95% CI = 0.38–0.84).

Adverse reactions occurring in at least 20% of patients receiving gilteritinib were increased transaminase, myalgia/arthralgia, fatigue/malaise, fever, mucositis, edema, rash, noninfectious diarrhea, dyspnea, nausea, cough, constipation, eye disorders, headache, dizziness, hypotension, vomiting, and renal impairment. Prescribing information contains a Boxed Warning alerting health-care professionals and patients about the risk of differentiation syndrome, which may be life-threatening or fatal if not treated.

The recommended gilteritinib dose is 120 mg orally once daily.

View the full prescribing information for gilteritinib.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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