20 July 2023 - Today, the FDA approved quizartinib (Vanflyta, Daiichi Sankyo) with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukaemia that is FLT3 internal tandem duplication positive, as detected by an FDA approved test.
FDA also approved LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Vanflyta.