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US FDA approves Daiichi Sankyo’s acute myeloid leukaemia treatment
2023-07-21
上市批准
Vanflyta is claimed to be the first and only FLT3 inhibitor to receive FDA approval for treating FLT3-ITD positive AML. Credit: Nemes Laszlo / Shutterstock.com.
Vanflytaood and Drug Administration (FDA) hasFLT3 inhibitorFLT3nted approval for DaiiFDA Sankyo’s Vanflyta (quiFLT3-ITD positive AMLults with recently diagnosed FLT3-ITD-positive acute myeloid leukaemia (AML).
The treFood and Drug Administration (FDA)tandard cytarabine and antDaiichi SankyouctVanflytacyquizartinibnsolidation, as well as for maintenance trFLT3-ITD-positive acute myeloid leukaemia (AML)
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The company noted that Vanflyta is not intended for use as a maintenance monotherapy after allogeneic haematopoietic stem cell transplantation.
An oral type II FLT3 inhibitSiremadlin Succinate FLTMyelofibrosisns. It is claimed to be the first and only FLT3 inhibitor to receive FDA approval for treating FLT3-ITD-positive AML.
This FDA approval marks the third therSankyo Co Ltdchi Sankyo’s oncology pipeline to obtain approval in the country.
The latest development Vanflytad on findings from the QuANTUM-First trial in which Vanflyta was combined with standard cytarabine, anthracycline induction and standard cytarabine consolidation, and continued as maintenance monotherapy after consolidation.
The treatment reFLT3 inhibitorFLT3ed in a 22% Vanflytain mortality risk versus standard chemotherapy alone in AML patientsFLT3 inhibitorFLT3FDAFLT3-ITD-positive AML
DaiicFDASankyo oncology business global head, pDaiichi SankyoEO Ken Keller stated: “The FDA approval of Vanflyta is an important milestone, as patients with the FLT3-ITD subtype of AML can now be treated with the first-ever FLT3 inhibitor approved across the three phases of treatment these patients typically receive.
“Vanflyta represents the third oncology medicine from Daiichi Sankyo to be approvedVanflytaUS and reflects our commitmecytarabineinuously deliver innovative medicines tcytarabinee the current standard of care.”
In May 2023, the Japanese Ministry of Health, Labour and Welfare granted approval for Vanflyta fAMLthe same indication.
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