FLT3 and acute myeloid leukemia: Even within the subset of patients with FLT3-ITD-positive disease, the addition of sorafenib did not result in an improved EFS or OS, and was instead associated with an increased incidence of adverse events.80 Most recently, Rollig et al.81 investigated the combination of sorafenib with standard chemotherapy in a multicenter randomized controlled phase II trial of 267 patients age 60 or younger with newly diagnosed AML.