All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit Know AML.

The AML Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy
  TRANSLATE

The AML Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the AML Hub cannot guarantee the accuracy of translated content. The AML Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

Steering CommitteeAbout UsNewsletterContact

Quizartinib granted priority review by the FDA for patients with newly diagnosed FLT3-ITD AML

Oct 26, 2022
Share:
Learning objective: After reading this update, learners will be able to cite a new development in the treatment of AML.

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).

  1. Quizartinib granted priority review in the U.S. for patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia. https://www.daiichisankyo.com/files/news/pressrelease/pdf/202210/20221024_E2.pdf Published Oct 24, 2022. Accessed Oct 25, 2022.