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Daiichi Sankyo's Vanflyta Approved in Europe as First-Line Treatment for FLT3-ITD-Positive AML

NEW YORK – The European Commission on Thursday approved Daiichi Sankyo's Vanflyta (quizartinib) plus chemotherapy as a treatment for newly diagnosed acute myeloid leukemia (AML) patients with FLT3-internal tandem duplication (FLT3-ITD) mutations.

The FLT3 inhibitor can be used as part of a first-line and maintenance treatment regimen for these patients. The EC approved the drug for use in the first-line setting in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by Vanflyta single-agent maintenance therapy.

The EC's approval is based on data from the Phase III QuANTUM-First trial. In that study, Vanflyta reduced the risk of death by 22 percent compared to chemo alone. Median overall survival in the Vanflyta arm was 31.9 months compared to 15.1 months on chemo alone. In September, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval for the Vanflyta regimen based on this data.

The approval makes Vanflyta the first FLT3 inhibitor available in Europe for patients with newly diagnosed FLT3-ITD-positive AML. Up to 30 percent of newly diagnosed AML patients harbor such mutations.

US regulators approved Vanflyta in a similar indication earlier this year alongside Invivoscribe's LeukoStrat CDx FLT3 Mutation Assay for identifying treatment-eligible AML patients with FLT3-ITD mutations. Vanflyta is also approved in Japan for relapsed or refractory AML patients who are FLT3-ITD positive.