On July 20, 2023, Daiichi Sankyo Company, Limited – a global pharmaceutical giant, announced that for the treatment of adults with newly diagnosed FLT3 - ITD Positive Acute Myeloid Leukemia (AML) - an inhibitor, VANFLYTA (Quizartinib), has been approved by The US Food and Drugs Association in combination with anthracycline induction, standard cytarabine, and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy. 

The FLT3 - ITD mutation is present in around 37% of patients with AML, which is a common Leukemia form in adults. This mutation contributes to cancer growth and reduces the survival rate of patients. However, the approval of Daiichi Sankyo’s VANFLYTA is a sign of advancement in the treatment of patients with the mutation.

“The approval of VANFLYTA represents a significant advancement for the treatment of patients with newly diagnosed FLT3-ITD positive AML, which is one of the most aggressive and difficult-to-treat subtypes”. - Harry P. Erba of the Duke Cancer Institute.

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For specific treatment of FLT3 – ITD Positive AML, VANFLYTA is the first and only inhibitor approved by the FDA. It can be administered in adults with FLT3 - ITD Positive AML without transplant through induction, consolidation, and maintenance - the three stages of treatment without a transplant. 

“Today’s 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,” – Ken Keller, CEO, Daiichi Sankyo.

VANFLYTA has shown several benefits such as longer remission and prolonged survival.

“In the QuANTUM-First trial, VANFLYTA added to standard chemotherapy and continued as maintenance resulted in longer remission and prolonged overall survival and it will be a much-needed new treatment option that has the potential to change the way FLT3-ITD positive AML is treated.” – Harry P. Erba of the Duke Cancer Institute.

There are some contraindications of VANFLYTA as well - including patients that have a history of torsades de pointes, ventricular arrhythmias, or have long QT syndrome, hypokalemia, or severe hypomagnesemia.

However, it will be interesting to see how the approval of VANFLYTA will impact the treatment of AML patients with FLT3-ITD mutation moving forward. Daiichi Sankyo’s VANFLYTA was first approved in Japan by the Ministry of Health, Labour, and Welfare in 2019. It will now become available by prescription in the US in the upcoming weeks.