The Impact of Gilteritinib on Overall Survival of Adult Patients with FLT3 Positive Acute Myeloid Leukemia: A Systematic Review

Background: Gilteritinib, an effective and selective inhibitor of the FLT3 gene, was developed to address the challenges posed by relapsed or refractory acute myeloid leukemia (AML) patients who often encounter limited treatment options and poor prognoses with salvage chemotherapy. Aim: This systematic review aims to explore the progression of interventional research and consolidate existing evidence on the clinical effectiveness of gilteritinib as a monotherapy or combination therapy in improving overall survival among adults experiencing a recurrence or resistance to treatment for FLT3-positive AML patients. Methods: A comprehensive search strategy, utilizing Medical Subject Headings (MeSH) and non-MeSH terms was conducted across Pubmed, EMBASE, Cochrane, and Web of Science databases. We primarily focused on the clinical trial and retrospective studies on gilteritinib as an intervention for relapsed/refractory AML patients. Results: According to our predefined criteria for inclusion and exclusion, we identified 3 published clinical trials and 5 retrospective studies focused on the overall response of gilteritinib on refractory or relapsed AML adult patients published between January 1, 2018, and March 25, 2024. Clinical trial studies demonstrated superior survival outcomes than salvage chemotherapy in the FLT3-positive AML population particularly showing higher efficacy in combination therapy with Azacitidine. Retrospective studies from clinical trials revealed improved clinical outcomes in AML sub-populations. Conclusion: Gilteritinib exhibited promising outcomes by targeting FLT3 receptors, offering a new treatment approach, and revealing improved overall survival compared to salvage chemotherapy in the difficult-to-treat patient population.