AML Contender Quizartinib Gains First Approval, In Japan
Japan grants first approval worldwide for Daiichi Sankyo's oral FLT3 inhibitor, marking progress for Japanese firm's global oncology ambitions.
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Japanese company Daiichi Sankyo has its eye on first-line FLT3-ITD AML indication after rejection of relapsed/refractory plans in EU and US.
Following green lights in the US and Japan, Xospata has been approved for relapsed or refractory FLT3-positive acute myeloid leukemia. Getting first-line approval is the next step.
Will regulators in the EU follow their US counterparts in requiring more efficacy data for Daiichi Sankyo’s acute myeloid leukemia drug quizartinib, which is already approved in Japan?