The European Commission (EC) has approved an indication expansion for luspatercept (Reblozyl®) to include first-line therapy for adult patients with transfusion-dependent anemia due to lower-risk myelodysplastic syndromes (MDS), according to a press release from Bristol Myers Squibb.
“With this approval for Reblozyl® as a first-line treatment for anemia in adults with lower-risk MDS, more patients in the [European Union] will have the potential to become transfusion-independent for longer periods of time compared to current options available,” said Monica Shaw, MD, Senior Vice President and Head of European Markets at Bristol Myers Squibb.
The approval by the EC was based on positive data from the phase III COMMANDS study. COMMANDS compared luspatercept against epoetin alfa for managing anemia in transfusion-dependent patients with very low-, low-, or intermediate-risk MDS. The primary endpoint was red blood cell transfusion-independence for 12 weeks plus a mean hemoglobin increase of 1.5 g/dL or more.
“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,” commented Matteo Giovanni Della Porta, MD, a study investigator and the Head of Leukemia Unit at Humanitas Cancer Center in Milan, Italy. “This approval represents a significant milestone towards improving treatment practice and offering better outcomes for patients.”
Related: Panel Reacts to Full Analysis of the COMMANDS Trial of Luspatercept for MDS
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