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


Now you can personalise
your AML Hub experience!

Bookmark content to read later

Select your specific areas of interest

View content recommended for you

Find out more

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
You're logged in! Click here any time to manage your account or log out.
You're logged in! Click here any time to manage your account or log out.

SLS009 granted orphan drug designation by the EMA

Jul 9, 2024
Learning objective: After reading this article, learners will be able to cite a new clinical development in the treatment of acute myeloid leukemia.

On July 8, 2024, the European Medicines Agency (EMA) granted Orphan Drug Designation to SLS009, a highly selective CDK9 inhibitor, for the treatment of patients with acute myeloid leukemia (AML). SLS009 was previously granted Orphan Drug Designation and Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of AML. 

SLS009 is currently being investigated in combination with azacitidine and venetoclax in an open-label, single arm phase IIa clinical trial (NCT04588922), to evaluate its safety, tolerability, and efficacy, at two dose levels, 45 and 60 mg in patients with relapsed/refractory AML, including those with ASXL1 mutations.  

  1. GlobeNewswire. SELLAS Receives European Medicines Agency Orphan Drug Designation for SLS009 for the Treatment of Acute Myeloid Leukemia. SELLAS Receives European Medicines Agency Orphan Drug ( Published July 08, 2024. Accessed July 09, 2024. 


Subscribe to get the best content related to AML delivered to your inbox