SLS009 granted orphan drug designation by the EMA

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.