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FDA Clears Daiichi Sankyo’s Newly Diagnosed Acute Myeloid Leukemia Drug


Approval of Vanflyta comes nearly four years after initial rejection.

Blast cell (Acute myeloid leukemia in Human)

Image Credit: Adobe Stock Images/Pichitchai

In a company press release, Daiichi Sankyo revealed that Vanflyta, a medication for patients diagnosed with newly diagnosed acute myeloid leukemia (AML), has been approved by the FDA. As the first FLT3 inhibitor to be approved by the agency for FLT3-ITD positive AML across three phases of treatment, Vanflyta is expected to be available in the US in the coming weeks.

“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,” said Ken Keller, global head of oncology business, President, CEO, Daiichi Sankyo, Inc. “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.”

Reference: VANFLYTA® First FLT3 Inhibitor Approved in the U.S. Specifically for Patients with Newly Diagnosed FLT3-ITD Positive AML. Daiichi Sankyo. July 20, 2023. Accessed July 24, 2023. https://daiichisankyo.us/press-releases/-/article/vanflyta-first-flt3-inhibitor-approved-in-the-u-s-specifically-for-patients-with-newly-diagnosed-flt3-itd-positive-aml

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