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Quizartinib granted approval by the EC for patients with newly diagnosed FLT3-ITD-mutated AML
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On November 9, 2023, quizartinib, an oral selective type II FLT3 inhibitor, was approved by the European Commission (EC) in combination with standard cytarabine and anthracycline induction, standard cytarabine consolidation chemotherapy, and as a maintenance monotherapy for the treatment of adult patients with newly diagnosed FLT3-ITD-mutated acute myeloid leukemia.1
This approval is based on a recent positive opinion by the European Medicines Agency’s Committee of Medicinal Products for Human Use, previously covered by the AML Hub, and results from the QuANTUM-First trial (NCT02668653).1 Quizartinib has also been approved by the U.S. Food and Drug Administration and in Japan for the same indication.
- Daiichi-Sankyo. VANFLYTA approved in the EU as the first FLT3 inhibitor specifically for patients with newly diagnosed FLT3-ITD positive AML. https://www.daiichisankyo.com/files/news/pressrelease/pdf/202311/20231109_E.pdf. Published Nov 9, 2023. Accessed Nov 9, 2023.
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