Daiichi Sankyo’s Vanflyta Receives the US FDA’s Approval for Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia
Shots:
- The US FDA has approved Vanflyta in combination with standard cytarabine and anthracycline induction and cytarabine consolidation & as maintenance monotx., following consolidation CT for adult patients with newly diagnosed AML i.e., FLT3-ITD+
- The approval was based on the P-III trial (QuANTUM-First) results published in The Lancet evaluating Vanflyta + standard induction and consolidation therapy incl. HSCT & as maintenance monotx. in a ratio (1:1) in 539 patients aged 18-75yrs. at 193 study sites across Asia, the EU, North & South America, and Oceania
- The results showed a 22% reduction in risk of death, CR rates were similar b/w both arms, and the median duration of CR (38.6 vs 12.4mos.) in PBO + standard CT alone. The therapy is expected to be available by prescription in the US in the coming weeks
Ref: Businesswire | Image: Daiichi Sankyo
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