Daiichi Sankyo’s FLT3 Inhibitor VANFLYTA Approved by the FDA in the US.

Published: Jul 2023

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.