Daiichi Sankyo’s Vanflyta (quizartinib) Receives the MHLW’s Approval for Newly Diagnosed FLT3-ITD Positive AML
Shots:
- 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
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
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.
