The US Food and Drug Administration (FDA) has approved luspatercept-aamt (Reblozyl®) for the treatment of anemia without previous erythropoiesis-stimulating agent use in adult patients with myelodysplastic syndromes (MDS) who may require regular red blood cell transfusions, Bristol Myers Squibb announced.

“For patients with lower-risk MDS, current standard therapies, including erythropoiesis-stimulating agents, have provided limited benefit in controlling anemia with only 1 in 3 patients responding for a duration of 6-18 months,” said Guillermo Garcia-Manero, MD, lead investigator and chief of the section of myelodysplastic syndromes at the University of Texas MD Anderson Cancer Center.

The FDA’s decision to expand the indication to the first-line setting is based on interim results from the pivotal phase 3 COMMANDS trial evaluating the efficacy and safety of luspatercept-aamt compared with epoetin alfa.

According to the study results, 86 patients (58.5%) treated with luspatercept-aamt compared with 48 patients (31.2%) treated with epoetin alfa achieved the primary endpoint of red blood cell transfusion independence of at least 12 weeks with a mean hemoglobin increase of at least 1.5 g/dL within the first 24 weeks.

Read more about MDS experimental therapies

The patients reported diarrhea, fatigue, hypertension, peripheral edema, nausea, and dyspnea as the most common adverse reactions.

In June, the results of the COMMANDS study were part of the press program at the American Society of Clinical Oncology (ASCO) Annual Meeting as well as the plenary session at the European Hematology Association (EHA) Congress. The results of the study have also been published in The Lancet.

Luspatercept-aamt is a first-in-class therapeutic that may promote late-stage red blood cell maturation. It cannot be used as a substitute for red blood cell transfusions in patients who require immediate correction of anemia or patients with nontransfusion-dependent beta-thalassemia.


US FDA approves Bristol Myers Squibb’s Reblozyl® (luspatercept-aamt) as first-line treatment of anemia in adults with lower-risk myelodysplastic syndromes (MDS) who may require transfusions. News release. Bristol Myers Squibb; August 28, 2023.