This website is intended for US Healthcare Professionals.
This website is intended for US Healthcare Professionals.
Request a RepINDICATIONS
REBLOZYL® (luspatercept-aamt) is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
REBLOZYL® (luspatercept-aamt) is indicated for the treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.
REBLOZYL® (luspatercept-aamt) is indicated for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.
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a Rep 
Luspatercept-aamt (REBLOZYL®) is recommended by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a first-line treatment option for symptomatic anemia in lower-risk MDS1*
REBLOZYL FOR FIRST-LINE TREATMENT OF ANEMIA DUE TO LR-MDS
Based on a head-to-head study vs epoetin alfa‡
REBLOZYL raises the standard of care in 1L LR-MDS–associated anemia2,3
REBLOZYL FOR FIRST-LINE TREATMENT OF ANEMIA DUE TO LR-MDS
Based on a head-to-head study vs epoetin alfa‡
REBLOZYL raises the standard of care in 1L LR-MDS–associated anemia2,3
Superior Efficacy2
REBLOZYL provides superior Hgb improvement and RBC-TI vs epoetin alfa.2
For patients with IPSS-R very low-, low-, or intermediate-risk MDS non-del(5q) ± other cytogenetic abnormalities and RS <15% (or RS <5% with an SF3B1 mutation) with sEPO ≤500 mU/mL.1
In patients with sEPO levels <500 U/L.2
>90% of study participants were outside of the United States and used a non-US-licensed epoetin alfa product. Direct comparisons between REBLOZYL and US-licensed epoetin alfa product have not been established.2
STUDY DESIGN2,3
COMMANDS (N=356) was a Phase 3, randomized, open-label, active-controlled trial comparing REBLOZYL vs epoetin alfa in adult patients with anemia due to IPSS-R very low-, low-, or intermediate-risk MDS, with or without ring sideroblasts, who were ESA-naive (with endogenous sEPO levels <500 U/L) and required RBCT. Patients with del(5q) and those previously treated with disease-modifying agents or HMAs were excluded.
Patients were randomized to either REBLOZYL (n=178) 1 mg/kg SC Q3W, with titration up to max 1.75 mg/kg if needed to achieve response, or epoetin alfa (n=178) 450 IU/kg SC QW max total dose 40K IU, with titration up to 1050 IU/kg max total dose 80K IU. The primary endpoint was RBC-TI with a mean improvement in Hgb by at least 1.5 g/dL for any consecutive 12-week period during Weeks 1 to 24.
EFFICACY RESULTS2,3,6,7
Primary endpoint (RBC-TI for ≥12 weeks with concurrent mean Hgb increase ≥1.5 g/dL): 58.5% (n=86/147; 95% CI: 50.1, 66.6) of patients in the REBLOZYL treatment group and 31.2% (n=48/154; 95% CI: 24.0, 39.1) of patients in the epoetin alfa treatment group achieved RBC-TI with Hgb increase during Weeks 1 to 24.
Key secondary endpoints included HI-E per IWG ≥8 weeks (Weeks 1-24): REBLOZYL 74.1% (n=109/147), epoetin alfa 51.3% (n=79/154); RBC-TI for 24 weeks (Weeks 1-24): REBLOZYL 47.6% (n=70/147), epoetin alfa 29.2% (n=45/154); and RBC-TI for ≥12 weeks (Weeks 1-24): REBLOZYL 66.7% (n=98/147), epoetin alfa 46.1% (n=71/154). Other secondary endpoints included median duration (weeks) of RBC-TI ≥12 weeks (Week 1 to EOT): REBLOZYL 126.6 weeks (95% CI: 108.3, NR), epoetin alfa 77.0 weeks (95% CI: 39.0, NR). Both treatments were dose modified targeting Hgb between 10-12 g/dL and Tl.
1L=first-line; CI=confidence interval; EOT=end of treatment; EPO=erythropoietin; ESA=erythropoiesis-stimulating agent; Hgb=hemoglobin; HI- E=hematologic improvement-erythroid; HMA=hypomethylating agent; IPSS-R=Revised International Prognostic Scoring System; IWG=International Working Group; LR-MDS=lower-risk myelodysplastic syndromes; MDS=myelodysplastic syndromes; NCCN=National Comprehensive Cancer Network; NR=not reached; QW=once a week; Q3W=once every 3 weeks; RBCT=red blood cell transfusion; RBC- TI=red blood cell transfusion independence; RS=ring sideroblast; SC=subcutaneous; sEPO=serum erythropoietin; TI=transfusion independence.