BMS’s Reblozyl gains FDA approval for anaemia treatment in adults with myelodysplastic syndromes
Bristol Myers Squibb (BMS) has announced that the US Food and Drug Administration (FDA) has approved Reblozyl (luspatercept-aamt) for the treatment of anaemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with low- to intermediate-risk myelodysplastic syndromes (MDS) who may need regular red blood cell (RBC) transfusions.
The expanded indication to the first-line setting follows interim results from the pivotal phase 3 COMMANDS trial, throughout which the drug has demonstrated superior efficacy of concurrent RBC transfusion independence (RBC-TI) and haemoglobin (Hb) increase compared to epoetin alfa, an ESA, regardless of ring sideroblast status.
Guillermo Garcia-Manero MD, lead investigator andchiefoftheSectionofMyelodysplasticSyndromes at the University of Texas MD Anderson Cancer Center, US, commented: “For patients with lower-risk MDS, current standard therapies, including ESAs, have provided limited benefit in controlling anaemia, with only one in three patients responding for a duration of six to 18 months. Results from the COMMANDS study showed nearly twice as many patients treated with Reblozyl achieved transfusion independence of at least 12 weeks and concurrent haemoglobin increase compared to epoetin alfa. Today’s approval represents an important advancement for patients with lower-risk MDS.”
Tracey Iraca, executive director of the MDS Foundation, added: “The majority of patients with MDS experience chronic anemia and require RBC transfusions. The approval of Reblozyl in the first-line treatment of anemia for patients with lower-risk MDS represents a crucial step in making transfusion independence possible for more patients.”