European Commission Expands Approval of Bristol Myers Squibb’s Reblozyl (luspatercept) to Include First-Line Treatment of Transfusion-Dependent Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (LR-MDS)

Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has expanded approval of Reblozyl (luspatercept) to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS). This approval of Reblozyl covers 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. “This milestone underscores our ongoing commitment to developing new options for patients with disease-related anemia.”

The approval is based on the pivotal Phase 3 COMMANDS study, in which Reblozyl demonstrated superior efficacy compared to epoetin alfa, an erythropoiesis stimulating agent, in the study’s primary endpoint of concurrent red blood cell transfusion independence and hemoglobin increase. Safety results were consistent with previous MDS studies and were in line with expected symptoms in this patient population. Reblozyl is also approved in the United States and Japan for the first-line treatment of anemia associated with lower-risk MDS.

“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,” said Matteo Giovanni Della Porta, M.D., study investigator and head of Leukemia Unit at Humanitas Cancer Center in Milan, Italy. “Results from the COMMANDS study underscore the clinical value of Reblozyl as an initial treatment for anemia in patients with low- to intermediate-risk MDS, and this approval represents a significant milestone towards improving treatment practice and offering better outcomes for patients.”

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

About COMMANDS

COMMANDS (NCT03682536) is a Phase 3, open-label, randomized study evaluating the efficacy and safety of Reblozyl versus epoetin alfa for the treatment of anemia due to very low-, low- or intermediate-risk (IPSS-R) myelodysplastic syndromes (MDS) in patients who are red blood cell (RBC) transfusion dependent and were erythropoiesis stimulating agent (ESA)-naïve.