Quizartinib Recommended for Approval in EU by CHMP for Patients with Newly Diagnosed FLT3-ITD Positive AML
“Today’s positive CHMP opinion for quizartinib is an important step towards translating the clinical benefit observed in QuANTUM-First into an approved treatment option for patients in the EU with the difficult-totreat FLT3-ITD subtype of acute myeloid leukemia,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo. “If approved, quizartinib would be the first FLT3 inhibitor approved specifically for patients with newly diagnosed FLT3-ITD positive AML.”
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