Quizartinib Granted Priority Review in the U.S. for Patients with Newly Diagnosed FLT3-ITD Positive AML

“There is a need for new targeted therapy options for patients with acute myeloid leukemia and the results of the QuANTUM-First trial showed that quizartinib in combination with standard chemotherapy has potential to change the current standard of care for newly diagnosed patients with the historically difficult to-treat FLT3-ITD subtype,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “The FDA’s prioritization of this application reflects the importance of the data, and we will continue to work with the FDA and other global regulatory authorities to support the review of quizartinib for the treatment of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia.”