Daiichi Sankyo’s Vanflyta (quizartinib) Receives the MHLW’s Approval for Newly Diagnosed FLT3-ITD Positive AML


The approval was based on the P-III trial (QuANTUM-First) published in The Lancet evaluating Vanflyta + CT & as maintenance monotx. following consolidation vs PBO + CT in a ratio (1:1) in 539 patients aged 18-75yrs. at 193 study sites across Asia, the EU, North America, Oceania & South America
The results showed a 22.4% reduction in risk of death, m-OS (31.9 vs 15.1mos.) after a median follow-up of 39.2mos. The safety profile was consistent with previous use with no new safety concerns
Vanflyta, an oral, highly potent type II FLT3 inhibitor selectively targeting FLT3-ITD mutations. The regulatory applications for Vanflyta are currently under the EMA & US FDA’s review, based on (QuANTUM-First) trial results

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