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Japanese Approval Sought for Quizartinib in FLT3-ITD+ AML

Jason M. Broderick @jasoncology
Published: Wednesday, Oct 17, 2018

blood cellsA 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-ITD–positive relapsed/refractory AML after first-line treatment with or without hematopoietic stem cell transplantation (HSCT).

At a median follow-up of 23.5 months, the median overall survival (OS) was 6.2 months (95% CI, 5.2-7.2) with quizartinib compared with 4.7 months (95% CI, 4.0-5.5) with salvage chemotherapy (HR, 0.76; 95% CI, 0.58-0.98; stratified log-rank test, 1-sided P = .0177).

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