Bristol Myers Squibb gets USFDA nod for Reblozyl as first line treatment of Anemia in lower risk MDS
Reblozyl, a first-in-class therapeutic option, promotes late-stage red blood cell maturation in animal models.;
Princeton: Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has approved Reblozyl (luspatercept-aamt) for the treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.
This expanded indication to the first-line setting is based on interim results from the pivotal Phase 3 COMMANDS trial, in which Reblozyl demonstrated superior efficacy of concurrent RBC transfusion independence (RBC-TI) and hemoglobin (Hb) increase compared to epoetin alfa, an ESA, regardless of ring sideroblast status. These results underscore Reblozyl’s ability to address chronic anemia earlier in the treatment journey in a broader range of patients.
“For patients with lower-risk MDS, current standard therapies, including ESAs, have provided limited benefit in controlling anemia with only 1 in 3 patients responding for a duration of 6-18 months,” said Guillermo Garcia-Manero, M.D., lead investigator and Chief of the Section of Myelodysplastic Syndromes at The University of Texas MD Anderson Cancer Center. “Results from the COMMANDS study showed nearly twice as many patients treated with Reblozyl achieved transfusion independence of at least 12 weeks and concurrent hemoglobin increase compared to epoetin alfa. The approval represents an important advancement for patients with lower-risk MDS.”
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