Bristol Myers Squibb (NYSE: BMY) has announced the European Commission's (EC) expanded approval of Reblozyl® (luspatercept) for the first-line treatment of adult patients with transfusion-dependent anemia associated with very low, low, and intermediate-risk myelodysplastic syndromes (MDS) across all EU member states.

“With this approval for Reblozyl as a first-line treatment for anemia in adults with lower-risk MDS, more patients in the EU will have the potential to become transfusion independent for longer periods of time compared to current options available,” said Monica Shaw, M.D., senior vice president and head of European Markets, Bristol Myers Squibb.

The decision to expand Reblozyl's approval was based on data from the pivotal Phase 3 COMMANDS study. Reblozyl exhibited superior efficacy over epoetin alfa, an erythropoiesis stimulating agent, in achieving concurrent red blood cell transfusion independence and hemoglobin increase. Safety results were consistent with previous MDS studies, with expected symptoms observed in the patient population.

Reblozyl marks the fourth authorized indication in Europe and is the first therapy to demonstrate superior efficacy versus epoetin alfa in LR-MDS. This milestone underscores Bristol Myers Squibb's commitment to addressing the unmet needs of patients with disease-related anemia.

“In the treatment of lower-risk MDS, few patients experience a lasting response to erythroid stimulating agents, leaving a critical need for more effective treatment options to address the burden of their anemia,” remarked Matteo Giovanni Della Porta, M.D., study investigator and head of Leukemia Unit at Humanitas Cancer Center in Milan, Italy.

Reblozyl is also approved in the United States and Japan for the first-line treatment of anemia associated with lower-risk MDS.

Centralized Marketing Authorization does not include approval in Great Britain (England, Scotland, and Wales).