Summary

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• Xospata (gilteritinib) is indicated for the treatment of refractory or relapsed acute myeloid leukemia in adults with an FLT3 mutation as detected by an FDA-approved test.
• This summary is based on the review of four systematic review(s)/meta-analysis(es). ^[1-4]
• In patients with FLT3-mutated relapsed and/or refractory acute myeloid leukemia (rrAML), gilteritinib showed a median survival of 9.3 months, which was lower than gemtuzumab ozogamicin (13.8 months) but higher than low-dose cytarabine (5.6 months) and best supportive care (3.2 months). Transplant rates were 25.5% with gilteritinib compared to 19% with gemtuzumab ozogamicin.
• Gilteritinib improved complete remission (RR 0.88, p = 0.04) and overall survival (HR 0.60, p < 0.01) in untreated AML and FLT3(+) rrAML, with significant improvements in relapse-free survival (HR 0.40, p = 0.01). In a meta-analysis of 2656 patients, FLT3 inhibitors, including gilteritinib, improved overall survival (HR 0.83), event-free survival (HR 0.85), and relapse-free survival (HR 0.76).
• Gilteritinib demonstrated the highest probability for improved prognosis in a network meta-analysis (NMA) when compared to other FLT3 inhibitors, such as midostaurin and quizartinib.
• FLT3 inhibitors, including gilteritinib, demonstrated significantly increased risks of thrombocytopenia, neutropenia, anemia, skin- and cardiac-related adverse effects, elevated alanine aminotransferase, and respiratory issues such as cough and dyspnea (p < 0.05).
• FLT3 inhibitors were associated with a higher relative risk of grade 3 and above vascular, dermatological, respiratory, and hepatobiliary adverse events compared to control.
• Gilteritinib demonstrated improved survival, complete remission rates, and relapse-free survival in FLT3-mutated rrAML, with notable benefits in untreated AML and post allo-HSCT patients using FLT3 inhibitors.