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

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Daiichi Sankyo

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

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  • 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

Ref: Daiichi Sankyo | Image: Daiichi Sankyo

Related News:- Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) Receives the MHLW’s Approval as the First HER2 Directed Therapy for HER2 Low Metastatic Breast 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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