FDA Approves Daiichi Sankyo's Quizartinib as First-Line Treatment for AML with Boxed Warning for Heart Disorders
The FDA has approved Daiichi Sankyo's Vanflyta (quizartinib) as a first-line treatment option for patients with FLT3-ITD-positive acute myeloid leukemia (AML). The drug can be used in combination with chemotherapy and as a maintenance monotherapy after initial treatment. A companion diagnostic has also been approved to detect the mutation.