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.

The US Food and Drug Administration (FDA) has granted approval for Daiichi Sankyo’s Vanflyta (quizartinib) to treat adults with recently diagnosed FLT3-ITD-positive acute myeloid leukaemia (AML).

The treatment is indicated for use with standard cytarabine and anthracycline induction and cytarabine consolidation, as well as for maintenance treatment after consolidation chemotherapy.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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 inhibitor, Vanflyta acts on FLT3-ITD mutations. 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 therapy from Daiichi Sankyo’s oncology pipeline to obtain approval in the country.

The latest development was based 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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The treatment resulted in a 22% decline in mortality risk versus standard chemotherapy alone in AML patients. 

Daiichi Sankyo oncology business global head, president and CEO 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 approved in the US and reflects our commitment to continuously deliver innovative medicines that improve the current standard of care.”

In May 2023, the Japanese Ministry of Health, Labour and Welfare granted approval for Vanflyta for the same indication.