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Daiichi Sankyo Receives US FDA Approval for VANFLYTA® First FLT3 Inhibitor

Friday, July 21, 2023

Daiichi Sankyo announced that VANFLYTA® (quizartinib) has received approval from the U.S. Food and Drug Administration (FDA) for a comprehensive treatment approach in adult patients with newly diagnosed acute myeloid leukaemia (AML) who test positive for FLT3-ITD as determined by an FDA-approved test.

VANFLYTA is the first and only FLT3 inhibitor approved by the FDA for FLT3-ITD positive AML across all three phases of treatment – induction, consolidation, and maintenance – for patients who do not undergo transplant. This means that patients with this specific type of AML can receive VANFLYTA throughout their treatment journey.

VANFLYTA is an oral, highly potent, type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for patients with FLT3-ITD positive AML. 

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.

The approval of VANFLYTA also extends to Japan, where it is approved for the treatment of AML that is FLT3-ITD mutation positive. In Japan, it is approved for use in combination with standard cytarabine and anthracycline induction, standard cytarabine consolidation chemotherapy, and as maintenance monotherapy for adult patients with newly diagnosed FLT3-ITD positive AML. 

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