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Daiichi Sankyo’s Vanflyta Receives the US FDA’s Approval for Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia

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Daiichi Sankyo’s Vanflyta Receives the US FDA’s Approval for Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia

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  • 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

Related News:- Daiichi Sankyo and AstraZeneca Report P-III Trial (TROPION-Lung01) Results of Datopotamab Deruxtecan for Advanced Non-Small Cell Lung Cancer

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Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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