Trial Profile
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) ESA in Native Subjects Who Require Red Blood Cell Transfusions
Status:
Active, no longer recruiting
Phase of Trial:
Phase III
Latest Information Update: 13 Mar 2024
Price :
$35
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At a glance
- Drugs Luspatercept (Primary) ; Epoetin alfa
- Indications Anaemia; Myelodysplastic syndromes
- Focus Registrational; Therapeutic Use
- Acronyms COMMANDS
- Sponsors Celgene Corporation
- 23 Feb 2024 According to a Bristol-Myers Squibb media release, company announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Reblozyl (luspatercept) as a treatment for adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS). The CHMP adopted a positive opinion based on results from this pivotal Phase 3 COMMANDS trial.
- 12 Dec 2023 Results(As of Mar 31, 2023,n=182) full efficacy and safety analysis of this study , presented at the 65th American Society of Hematology Annual Meeting and Exposition
- 12 Dec 2023 Results (n=145) investigating the association between the most frequent CHIP-related mutations (DNMT3A, TET2, ASXL1, SF3B1) and clinical outcomes in patients treated with luspatercept, presented at the 65th American Society of Hematology Annual Meeting and Exposition