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FDA approves Daiichi Sankyo’s Vanflyta® (quizartinib) combination and as monotherapy to treat FLT3-ITD+ AML

Jul 20, 2023

Daiichi Sankyo announced that the FDA has approved its Vanflyta® (quizartinib) in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, to treat patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive as detected by an FDA-approved test.  Vanflyta® is the first and only FLT3 inhibitor approved by the FDA for FLT3-ITD positive AML for all three phases of treatment (induction, consolidation and maintenance) in patients without a transplant and newly diagnosed AML.  Daiichi confirmed that Vanflyta® will be available in the US in the coming weeks.

On 12 July 2023, AstraZeneca and Daiichi’s Enhertu® (trastuzumab deruxtan) was approved for a new indication (unresectable or metastatic HER2-low breast cancer).