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 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.
The AML Hub is an independent medical education platform, sponsored by Astellas, Daiichi Sankyo, Johnson & Johnson, Kura Oncology and Syndax, and has been supported through educational grants from Bristol Myers Squibb and the Hippocrate Conference Institute, an association of the Servier Group. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out more
Create an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View aml content recommended for you
Quizartinib granted priority review by the FDA for patients with newly diagnosed FLT3-ITD 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).
References
Please indicate your level of agreement with the following statements:
The content was clear and easy to understand
The content addressed the learning objectives
The content was relevant to my practice
I will change my clinical practice as a result of this content
