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FDA Grants Quizartinib Breakthrough Designation for FLT3-ITD+ AML

Jason M. Broderick @jasoncology
Published: Wednesday, Aug 01, 2018

Arnaud Lesegretain, Vice President, Oncology Research and Development and Head, AML Franchise, Daiichi Sankyo

Arnaud LesegretainD

The FDA has granted a breakthrough therapy designation to quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia (AML), according to Daiichi Sankyo, the manufacturer of the FLT3 inhibitor.

The designation, which will expedite the development and review of quizartinib in this setting, is based on findings from the phase III QuANTUM-R study, in which the FLT3 inhibitor 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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