Drug updated on 12/11/2024
| Dosage Form | Injection (subcutaneous; 25 mg/vial, 75 mg/vial) |
| Drug Class | Erythroid maturation agents |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions
- Indicated for the treatment of anemia without previous erythropoiesis stimulating agent use (ESA-nave) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions
- Indicated for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more 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).
Latest News
Summary
- This summary is based on the review of one systematic review/meta-analysis. [1]
- Erythroid Response: In Phase 2 trials, luspatercept (0.2 to 1.25 mg/kg) demonstrated a notable reduction in blood transfusion needs and an increase in hemoglobin levels, while Phase 3 trials (1.0 to 1.25 mg/kg) showed a more significant erythroid response compared to placebo.
- Quality of Life: Luspatercept potentially improved clinical outcomes and quality of life for patients by decreasing the requirement for red blood cell transfusions.
- Population Types: Among Phase 2 participants, 45.75% had transfusion-dependent beta-thalassemia (TD) and 54.25% had non-transfusion-dependent beta-thalassemia (NTD), with both groups responding positively to luspatercept treatment. All participants were aged 18 years and older.
- Adverse events associated with luspatercept included hyperuricemia, arthralgia, dizziness, influenza, hypertension, and bone pain, all of which were noted to be manageable.
- No specific safety concerns or significant adverse effects were highlighted for different population types or subgroups, including those with TD and NTD.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Reblozyl (luspatercept-aamt) Prescribing Information. | 2024 | Bristol-Myers Squibb Company, Summit, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and Safety of Luspatercept in the Treatment of beta-Thalassemia: A Systematic Review | 2022 | Cureus |