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# Daiichi Sankyo Breakthrough Status for Leukemia Therapy
- URL: https://www.fdaweb.com/daiichi-sankyo-breakthrough-status-for-leukemia-therapy/
- Published: 2018-08-01T12:00:00.000Z
- Updated: 2026-09-15T00:23:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142022

FDA has granted Daiichi Sankyo a breakthrough therapy designation for quizartinib, an investigational FLT3 inhibitor for treating adult patients with relapsed/refractory *FLT3*\-ITD acute myeloid leukemia, a very aggressive form of the disease associated with poor prognosis. Quizartinib is the first FLT3 inhibitor to significantly improve overall survival as an oral, single agent compared to chemotherapy in patients with the disease, according to the company. The designation was granted based on the results of the pivotal phase 3 QuANTUM-R study of quizartinib, which were presented during the plenary program at the 23rd Congress of the European Hematology Association in June.