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 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 an educational grant from 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
FDA grants Orphan Drug Designation to MAX-40279 for the treatment of AML
On 29 March 2018, the US Food and Drug Administration (FDA) granted Orphan Drug Designation to MAX-40279, a multi-kinase targeted inhibitor, for the treatment of patients with Acute Myeloid Leukemia (AML).
Mutations in the fms like tyrosine kinase (FLT3) gene represent one of the most commonly encountered, and clinically challenging, classes of AML mutations and it is expressed in approximately 30% of patients. MAX-40279 is a dual inhibitor of FLT3 and fibroblast growth factor receptor (FGFR). According to the drug manufacturers, MaxiNovel Pharmaceuticals, MAX-40279 “demonstrated potent inhibition of both FLT3 and FGFR with excellent drug concentration in the bone marrow” in preclinical studies. Additionally, MAX-40279 was designed to overcome the drug resistance experienced by current FLT3 inhibitors due to bone marrow FGF/FGFR pathway activation.
At present, MAX-40279 is being investigated in a phase I dose escalation study (NCT03412292), which is evaluating the safety and tolerability of MAX-40279 in patients with AML. The primary endpoints of the study include incidence of adverse events and determination of the maximum tolerated dose.
References