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Wednesday, August 1, 2018

FDA Grants Breakthrough Tag to Daiichi Sankyo Leukemia Med


FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo’s FLT3 Inhibitor Quizartinib for Relapsed/Refractory FLT3-ITD AML
・ Quizartinib has received FDA Breakthrough Therapy designation in patients with relapsed/refractory FLT3-ITD AML, a very aggressive form of the disease associated with poor prognosis
・ Significant unmet medical need exists in relapsed/refractory AML, as available treatment options are limited and there are no approved targeted therapies for patients with relapsed/refractory FLT3-ITD AML
・ Third Breakthrough Therapy designation granted by FDA for a compound in the oncology pipeline of Daiichi Sankyo, reinforcing the company’s commitment to transforming science into value for patients with cancer

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