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On October 24, 2022, it was announced that the U.S. Food and Drug Administration (FDA) had accepted a New Drug Application (NDA) and granted priority review to quizartinib for the treatment of adults with newly diagnosed FLT3-internal tandem duplication (ITD) acute myeloid leukemia (AML) in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as a continuation monotherapy following consolidation.1
Quizartinib is an oral, highly potent, and selective type II FLT3 inhibitor that has previously been rejected by the FDA and the European Medicines Agency (EMA) for the treatment of relapsed/refractory FLT3-ITD AML.
This current NDA is based on positive results from the phase III QuANTUM-First trial of quizartinib with standard chemotherapy and as continuation therapy in newly diagnosed FLT3-ITD AML (NCT02668653).
Quizartinib refused marketing authorization by EMA CHMP
The EMA CHMP refused marketing authorization to quizartinib for the treatment of patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) with a FLT3-internal tandem duplication
Quizartinib rejected by FDA for FLT3-ITD AML
The FDA has decided not to grant approval to quizartinib for the treatment of patients with FLT3-internal tandem duplication-positive relapsed/refractory (R/R) acute myeloid leukemia
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