FDA Approves Daiichi Sankyo's Quizartinib as First-Line Treatment for AML with Boxed Warning for Heart Disorders
TL;DR
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.
- FDA approves Daiichi Sankyo's new first-line AML drug quizartinib with boxed warning for heart disorders Endpoints News
- Japan's Daiichi Sankyo gets US FDA nod for blood cancer treatment Reuters.com
- FDA Approves Quizartinib Plus Chemotherapy for Newly Diagnosed, FLT3-ITD+ AML OncLive
- New Targeted Drug OK'd for Acute Myeloid Leukemia Medpage Today
- Daiichi scores FDA nod for leukemia med Vanflyta FiercePharma
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