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drugsProductNot mapped hereapproved

Luspatercept

An injection that helps the marrow finish making red cells, reducing or removing the need for transfusions in lower-risk MDS and beta-thalassaemia.

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).

Schematic of the modality · Erythroid maturation agent (activin receptor IIB ligand trap, Fc fusion) · not a molecule; see the Transfusion support and anaemia management page
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.
Brand / code
Reblozyl
Medicare
Part B (clinician-administered)

Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Subcutaneous injection every three weeks by a clinician; HCPCS J0896.

Commercial insurance
covered with prior authorisation

Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments. Transfusion burden and erythropoiesis-stimulating agent history documented for MDS.

20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.

Not yet researchedSearch NICE
Notes
Licensed 2020 for transfusion-dependent anaemia in lower-risk MDS with ring sideroblasts after ESA failure; NICE appraisals 2022-25 (including COMMANDS first-line use). Check NICE.

Sources: NICE search: luspatercept. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2019Beta-thalassaemia transfusion-dependent anaemia
US2020Very low- to intermediate-risk MDS with ring sideroblasts after ESA failure
US2023First-line anaemia in ESA-naive lower-risk MDS
EU2020MDS-RS and beta-thalassaemia

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
44 studies16 recruiting35 Phase 211 Phase 3
Search “Luspatercept” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Luspatercept
intervention: Luspatercept
Open on ClinicalTrials.gov →

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Key papers

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Luspatercept" OR ABSTRACT:"Luspatercept" OR TITLE:"Reblozyl" OR ABSTRACT:"Reblozyl") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Luspatercept, not a curated reading list.

Connected

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