On August 28, 2023, the U.S. Food and Drug Administration approved luspatercept-aamt (Re
Approval was based on the COMMANDS trial, a phase 3 study that included 356 patients with MDS, confirmed using the criteria mentioned above. Patients were randomly assigned in 1:1 ratio to either receive Luspatercept or eptoin
Efficacy was established on the primary endpoint of red blood cell transfusion independence (RBC-TI) for at least 12 weeks and a mean hemoglobin (Hb) increase of at least 1.5 g/dL within the first 24 weeks. 58.5% of patients receiving luspatercept-aamt ach
The study concluded that luspatercept-aamt showed superior efficacy in achieving RBC-TI and increasing Hb levels compared to epoetin alfa, representing an important advancement for patients with lower-risk MDS.