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Approval of Reblozyl is based on head-to-head, pivotal Phase 3 COMMANDS study, in which Reblozyl nearly doubled the percentage of patients achieving transfusion independence and hemoglobin increase, along with increased durability compared to epoetin alfa
This is the fourth authorized indication in Europe for Reblozyl, a first-in-class treatment for patients with disease-related anemia and the first therapy to demonstrate superior efficacy vs. epoetin alfa in LR-MDS
PRINCETON N.J.--(BUSINESS WIRE)-- 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.
The primary endpoint evaluated in this study is RBC transfusion independence (RBC-TI) for 12 weeks with a mean hemoglobin (Hb) increase ≥1.5 g/dL. Key secondary endpoints include erythroid response (HI-E) of at least 8 weeks during weeks 1-24 of the study, RBC-TI ≥12 weeks and RBC-TI for 24 weeks. Eligible patients were ≥18 years old with lower-risk MDS who require transfusions. Patients were randomized 1:1 to receive subcutaneous Reblozyl (starting dose 1.0 mg/kg, titration up to 1.75 mg/kg) once every 3 weeks or epoetin alfa (starting dose 450 IU/kg, titration up to 1050 IU/kg) weekly for ≥24 weeks.
At the time of the primary analysis (March 31, 2023), 363 patients were randomized 1:1 to Reblozyl and epoetin alfa. Results from the primary analysis of the intent to treat (ITT) population showed:
