Daiichi Sankyo：Vanflyta®Quizartinib marketing application submitted

On June 15, Daiichi Sankyo announced that its FLT3 inhibitor, Quizartinib Hydrochloride Tablets, has been approved for marketing in China. The drug is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have been confirmed via a validated test to carry the FMS-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) mutation. It is to be used in combination with standard-dose cytarabine and anthracyclines during induction therapy, in combination with cytarabine during consolidation therapy, and may be administered as a single-agent maintenance therapy following consolidation therapy.

Quizartinib is a selective inhibitor of the type III receptor tyrosine kinase FLT3, with potent binding affinity for wild-type FLT3, FLT3-ITD, and several FLT3 variants with point mutations in the kinase domain. Quizartinib binds with high affinity to the ATP-binding pocket of the inactive conformation of FLT3, inhibiting FLT3 kinase activity by preventing receptor autophosphorylation. This further suppresses downstream FLT3 receptor signaling, blocks FLT3-ITD-dependent cell proliferation, and enhances the differentiation of FLT3-mutant stem cells into mature circulating cells, including promoting leukemic cell death in certain cases.

Quizartinib received its first global approval in June 2019 in Japan. Subsequently, in July and November 2023, the drug was approved in the United States and Europe, respectively, under the brand name Vanflyta®. In China, the marketing application was accepted in January 2025 and has now been approved for marketing today.

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