Japanese Approval Sought for Quizartinib in FLT3-ITD+ AML

October 17, 2018 – A new drug application (NDA) has been submitted to Japan’s Ministry of Health, Labor and Welfare for quizartinib for the treatment of adult patients with FLT3-ITD–positive acute myeloid leukemia (AML), according to Daiichi Sankyo, the manufacturer of the FLT3 inhibitor. The NDA is based on data from the phase III QuANTUM-R study, in which quizartinib reduced the risk of death by 24% compared with salvage chemotherapy in patients with FLT3- … (leggi tutto)