FDA approves Vanflyta for newly-diagnosed AML

Vanflyta (quizartinib) has won US approval alongside standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for newly-diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive.

The US Food and Drug Administration (FDA) has also approved LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for the Daiichi Sankyo (TYO: 4568) drug, which gained approval following a slight delay in the regulatory review.

"The third oncology medicine from Daiichi Sankyo to be approved in the USA"AML is one of the most common forms of leukemia in adults and an estimated 20,380 new cases will be diagnosed in the USA in 2023. Up to 37% of newly-diagnosed patients have a FLT3 gene mutation and some 80% of these are FLT3-ITD mutations, which drive cancer growth and contribute to increased risk of relapse and shorter overall survival.