The European Commission (EC) has expanded approval of Reblozyl (luspatercept), a first-in-class treatment for patients with disease-related anemia, for the first-line treatment of adult patients with anemia due to very low to intermediate risk myelodysplastic syndromes (MDS). The decision is based on the Phase 3 COMMANDS study which demonstrated that Reblozyl almost doubled the percentage of patients achieving transfusion independence and a higher hemoglobin count, showing enhanced efficacy compared to epoetin alfa, a traditional treatment for anemia.
Reblozyl’s approval is a significant event in offering more effective options to adults suffering from lower-risk MDS in the EU. According to Monica Shaw, senior vice president and head of European Markets, Bristol Myers Squibb, the maker of Reblozyl, this drug gives patients the potential to become transfusion independent for a prolonged duration compared to available options. She also remarked that this achievement shows Bristol Myers Squibb’s continuous commitment to innovating new choices for patients with disease-related anemia.
Matteo Giovanni Della Porta, M.D., an investigator and head of the Leukemia Unit at the Humanitas Cancer Center in Milan, Italy, noted that the results from the COMMANDS study underscore Reblozyl’s clinical value as a starter treatment for anemia in patients with low to intermediate-risk MDS. The approval represents a significant milestone for improving treatment practices and ensuring better outcomes for patients, he said.
Reblozyl is also authorized for use for anemia linked with lower-risk MDS in Japan and the United States. The heightened approval for Reblozyl concerns all EU member states, except for Great Britain (England, Scotland, and Wales). It is the fourth licensed indication in Europe for this drug. The approval indicates a significant stride in improving treatment options for patients with anemia due to MDS in the EU countries.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
