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
China NMPA issue breakthrough therapy designation to APL-106 for relapsed/refractory AML
On January 7, 2021, the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) granted the E-selectin inhibitor APL-106 breakthrough therapy designation for the treatment of patients with relapsed/refractory (R/R) acute myeloid leukemia (AML).
The agent received investigational new drug approval in September 2020, which provided grounds for a future phase III bridging study of APL-106 in combination with chemotherapy for the treatment of R/R AML.1
APL-106
APL-106 is a first-in-class, investigational, targeted inhibitor of the E-selectin adhesion molecule.1 E-selectin is expressed in the bone marrow endothelium and is essential for physiological hematopoietic turnover. Upon interaction with AML cells, however, E-selectin can promote survival and regeneration, and is now a recognized contributor to AML chemoresistance.2
This newly introduced designation is designed to hasten the development and health authority review of APL-106 in R/R AML. Further research will demonstrate whether this new drug provides an advantage over existing treatment options.
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
Your opinion matters
Approximately what proportion of your patients with FLT3-mutations also have NPM1 and DNMT3A co-mutations?