On August 28, 2023, the US Food and Drug Administration (FDA) approved luspatercept-aamt (Reblozyl) as a first-line treatment for anemia in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.
This approval is based on interim results from the phase III COMMANDS trial, where luspatercept demonstrated superior efficacy compared to epoetin alfa, an erythropoiesis-stimulating agent (ESA). Specifically, 58.5% of patients treated with luspatercept achieved RBC transfusion independence for at least 12 weeks with a mean hemoglobin increase of at least 1.5 g/dL within the first 24 weeks, compared with 31.2% of patients treated with epoetin alfa.
The most common adverse reactions included diarrhea, fatigue, hypertension, peripheral edema, nausea, and dyspnea.
