{"entity":{"id":"luspatercept","kind":"drug","name":"Luspatercept","aka":[],"tldr":"An injection that helps the marrow finish making red cells, reducing or removing the need for transfusions in lower-risk MDS and beta-thalassaemia.","summary":"MEDALIST (2020) established transfusion independence in ring-sideroblast MDS after ESA failure; COMMANDS (2023) showed superiority to epoetin alfa in ESA-naive lower-risk MDS, making it a first-line option. Also approved in beta-thalassaemia (BELIEVE) and studied in myelofibrosis anaemia (INDEPENDENCE).","status":"approved","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Luspatercept","links":[{"label":"COMMANDS (Lancet 2023)","url":"https://doi.org/10.1016/S0140-6736(23)00874-7"},{"label":"Label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=luspatercept"}],"tags":["gap-fill"],"related":[],"cancers":["mds","myeloproliferative-neoplasms","mds-lower-risk"],"sections":[],"technologies":["transfusion-support"],"targets":[],"drugs":[],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":["nct04717414","nct04064060"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Reblozyl","modality":"Erythroid maturation agent (activin receptor IIB ligand trap, Fc fusion)","mechanism":"Binds TGF-β superfamily ligands (GDF11, activin B) to relieve SMAD2/3 suppression of late-stage erythropoiesis.","approvals":[{"region":"US","year":2019,"indication":"Beta-thalassaemia transfusion-dependent anaemia"},{"region":"US","year":2020,"indication":"Very low- to intermediate-risk MDS with ring sideroblasts after ESA failure"},{"region":"US","year":2023,"indication":"First-line anaemia in ESA-naive lower-risk MDS"},{"region":"EU","year":2020,"indication":"MDS-RS and beta-thalassaemia"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/luspatercept/","neighbours":{"cancer":[{"id":"cmml","kind":"cancer","name":"Chronic myelomonocytic leukaemia and MDS/MPN overlap neoplasms","route":"/cancers/cmml/"},{"id":"mds-lower-risk","kind":"cancer","name":"Lower-risk myelodysplastic syndromes","route":"/cancers/mds-lower-risk/"},{"id":"mds","kind":"cancer","name":"Myelodysplastic syndromes / neoplasms (MDS)","route":"/cancers/mds/"},{"id":"myeloproliferative-neoplasms","kind":"cancer","name":"Myeloproliferative neoplasms (PV, ET, myelofibrosis)","route":"/cancers/myeloproliferative-neoplasms/"},{"id":"primary-myelofibrosis","kind":"cancer","name":"Primary myelofibrosis","route":"/cancers/primary-myelofibrosis/"}],"technology":[{"id":"transfusion-support","kind":"technology","name":"Transfusion support and anaemia management","route":"/technologies/transfusion-support/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"}],"trial":[{"id":"nct04064060","kind":"trial","name":"A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials","route":"/trials/nct04064060/"},{"id":"nct04717414","kind":"trial","name":"An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomi","route":"/trials/nct04717414/"},{"id":"commands","kind":"trial","name":"COMMANDS","route":"/trials/commands/"},{"id":"medalist","kind":"trial","name":"MEDALIST","route":"/trials/medalist/"}],"paper":[{"id":"paper-commands-luspatercept-mds-lancet-2023","kind":"paper","name":"COMMANDS: luspatercept versus epoetin alfa as first treatment for anaemia in lower-risk MDS needing transfusions","route":"/key-papers/paper-commands-luspatercept-mds-lancet-2023/"},{"id":"paper-imerge-imetelstat-mds-lancet-2024","kind":"paper","name":"IMerge: imetelstat, a telomerase inhibitor, for transfusion-dependent lower-risk MDS after erythropoietin has failed","route":"/key-papers/paper-imerge-imetelstat-mds-lancet-2024/"}],"term":[{"id":"anaemia","kind":"term","name":"Anaemia","route":"/terms/anaemia/"},{"id":"del5q","kind":"term","name":"del(5q) (5q- syndrome and lenalidomide response)","route":"/terms/del5q/"},{"id":"ipss-m-ipss-r","kind":"term","name":"IPSS-R and IPSS-M (myelodysplastic syndrome risk scores)","route":"/terms/ipss-m-ipss-r/"},{"id":"sf3b1-mutation","kind":"term","name":"SF3B1 mutation","route":"/terms/sf3b1-mutation/"}],"target":[{"id":"smad2","kind":"target","name":"SMAD2","route":"/targets/smad2/"}]}}