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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Despite the emergence of the coronavirus pandemic at the end of the period, Japan’s regulatory authorities maintained an annual pace of new drug approvals on a par with the previous year, with expedited programs helping several drugs to market.
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.