A phase 3 trial evaluated the addition of midostaurin, a multitargeted kinase inhibitor, to standard chemotherapy in patients with acute myeloid leukemia (AML) and a FLT3 mutation. The study enrolled 3277 patients aged 18 to 59 years with newly diagnosed AML and FLT3 mutations. Patients were randomly assigned to receive standard chemotherapy plus midostaurin or placebo. Those in remission after consolidation therapy entered a maintenance phase with midostaurin or placebo. The primary endpoint was overall survival. The trial found that midostaurin significantly improved overall survival (hazard ratio for death, 0.78; one-sided P=0.009) and event-free survival (hazard ratio for event or death, 0.78; one-sided P=0.002) compared to placebo. The benefit was consistent across all FLT3 subtypes. The rate of severe adverse events was similar in both groups. Midostaurin was well tolerated, with no unexpected adverse events. The study showed that adding midostaurin to standard chemotherapy significantly prolonged overall and event-free survival in patients with AML and a FLT3 mutation. The trial was funded by the National Cancer Institute and Novartis. The results suggest that midostaurin is a valuable addition to standard chemotherapy for patients with AML and FLT3 mutations. The findings highlight the importance of targeting FLT3 mutations in AML treatment.A phase 3 trial evaluated the addition of midostaurin, a multitargeted kinase inhibitor, to standard chemotherapy in patients with acute myeloid leukemia (AML) and a FLT3 mutation. The study enrolled 3277 patients aged 18 to 59 years with newly diagnosed AML and FLT3 mutations. Patients were randomly assigned to receive standard chemotherapy plus midostaurin or placebo. Those in remission after consolidation therapy entered a maintenance phase with midostaurin or placebo. The primary endpoint was overall survival. The trial found that midostaurin significantly improved overall survival (hazard ratio for death, 0.78; one-sided P=0.009) and event-free survival (hazard ratio for event or death, 0.78; one-sided P=0.002) compared to placebo. The benefit was consistent across all FLT3 subtypes. The rate of severe adverse events was similar in both groups. Midostaurin was well tolerated, with no unexpected adverse events. The study showed that adding midostaurin to standard chemotherapy significantly prolonged overall and event-free survival in patients with AML and a FLT3 mutation. The trial was funded by the National Cancer Institute and Novartis. The results suggest that midostaurin is a valuable addition to standard chemotherapy for patients with AML and FLT3 mutations. The findings highlight the importance of targeting FLT3 mutations in AML treatment.