MEDALIST
MEDALIST showed that luspatercept let a substantial share of people with ring sideroblast myelodysplastic syndromes stop needing blood transfusions after erythropoietin had failed, which earned the drug its first approval.
Overview
MEDALIST randomised 229 patients with very low-, low- or intermediate-risk myelodysplastic syndromes with ring sideroblasts, regular red cell transfusion needs and prior failure of, or unsuitability for, erythropoiesis-stimulating agents to luspatercept or placebo every three weeks. The primary endpoint was red cell transfusion independence for eight weeks or longer in the first 24 weeks.
Significantly more patients on luspatercept became transfusion independent, many for long periods, with modest toxicity. The drug was approved in the United States in April 2020 for this population, the first new agent for lower-risk myelodysplastic anaemia in over a decade, and COMMANDS then took it into first-line use.
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