The ongoing Phase 2 study, sponsored by the French Innovative Leukemia Organisation, aims to evaluate the efficacy and safety of combining oral azacitidine with gilteritinib in adult patients with relapsed/refractory FLT3-mutated acute myeloid leukemia (AML). Given the high unmet medical need in this patient population, where less than 20% achieve complete remission with current treatments, successful outcomes could position this combination as a new standard of care. The market for AML therapies is growing, driven by the increasing incidence of the disease and the need for more effective treatments, particularly for patients with FLT3 mutations. Competitive dynamics will be influenced by the results of this trial, especially in relation to existing therapies like gilteritinib and other FLT3 inhibitors. Diligence should focus on the trial's recruitment progress, safety profile, and any emerging data that could impact market positioning.