FDA approves Reblozyl to treat anemia associated with lower-risk myelodysplastic syndromes. BMS + Acceleron
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Bristol Myers Squibb Canada and Acceleron Pharma Inc. announced that Health Canada has approved Reblozyl (luspatercept for injection) for the treatment of adult patients with transfusion-dependent anemia requiring at least two RBC red blood cell (RBC) units over 8 weeks resulting from very low-to intermediate-risk myelodysplastic syndromes (MDS) who have ring sideroblasts and who have failed or are not suitable for erythropoietin-based therapy.
Onconova Therapeutics announced that INSPIRE, the company’s pivotal Phase III study assessing the efficacy and safety of Estybon (IV rigosertib) in higher-risk myelodysplastic syndromes (HR-MDS) patients, did not meet its primary endpoint of improved survival.