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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Daiichi Sankyo is aiming to overcome past US and EU setbacks for its FLT3 inhibitor Vanflyta with planned filings for first-line AML on the back of positive new Phase III data.
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.