Luspatercept granted FDA approval as a first-line treatment for anemia in patients with lower-risk MDS

On August 28, luspatercept-aamt, a first-in-class erythroid-maturation agent, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of anemia in erythropoiesis-stimulating agent (ESA)-naïve, adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require red blood cell (RBC) transfusions.¹

Luspatercept-aamt was granted priority review by the FDA for the same indication, and was previously approved by the FDA and the European Medicines Agency (EMA) for the treatment of anemia in patients with MDS with ring sideroblasts who are transfusion-dependent and do not respond to or are ineligible for ESA treatment.

This approval is based on interim results from the open-label, randomized, phase III COMMANDS trial (NCT03682536), covered here on the MDS Hub, that found luspatercept-aamt to be associated with improved RBC transfusion independence and increased hemoglobin when compared with epoetin alfa, independent of ring sideroblast status, in patients with lower-risk MDS who are RBC transfusion-dependent and ESA-naïve.¹