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
Mutation testing in AML:
What you need to know
with Charles Craddock, Ralph Hills, and Gail Roboz
Wednesday, April 23, 2025
17:30-18:30 BST
This independent educational activity is supported by Thermo Fisher Scientific. All content is developed independently by the faculty. The funder is allowed no influence on the content.
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.
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.
FDA grants CC-486 priority review for the treatment of adult patients with AML
Bookmark this article
On May 1, 2020, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) and granted priority review to CC-486, an oral formulation of the hypomethylating agent azacitidine, for maintenance treatment of adult patients with acute myeloid leukemia (AML).
The NDA was based on the results of the phase III QUAZAR AML-001 study on patients with AML in complete remission (CR) or CR with incomplete blood count recovery (CRi) after induction therapy (with or without consolidation), who do not proceed to hematopoietic stem cell transplantation. The study showed a significant improvement in overall survival and relapse-free survival for patients receiving CC-486 maintenance treatment in comparison to patients in the placebo group. No unexpected adverse events were observed. Data from this trial were presented at the 61st American Society of Hematology (ASH) meeting by Andrew Wei, read more here.
The oral formulation of CC-486 allows for extended exposure to the drug, prolonging the therapeutic activity.
QUAZAR: Should maintenance with CC-486 become standard of care following induction chemotherapy?
- Business Wire. U.S. Food and Drug Administration (FDA) accepts for priority review Bristol Myers Squibb’s application for CC-486 for maintenance treatment of adult patients in remission with acute myeloid leukemia. https://www.businesswire.com/news/home/20200501005123/en/U.S.-Food-Drug-Administration-FDA-Accepts-Priority. Published May 1, 2020. Accessed May 4, 2020.
More about...
Your opinion matters
3 votes - 20 days left ...
Newsletter
Subscribe to get the best content related to AML delivered to your inbox