Bristol Myers announces FDA approval for Reblozyl

Bristol Myers announced that the FDA has approved Reblozyl for the treatment of anemia without previous erythropoiesis stimulating agent use in adult patients with very low- to intermediate-risk myelodysplastic syndromes who may require regular red blood cell transfusions. This expanded indication to the first-line setting is based on interim results from the pivotal Phase 3 COMMANDS trial, in which Reblozyl demonstrated superior efficacy of concurrent RBC transfusion independence and hemoglobin increase compared to epoetin alfa, an ESA, regardless of ring sideroblast status. These results underscore Reblozyl’s ability to address chronic anemia earlier in the treatment journey in a broader range of patients.