The approval was based on the P-III (COMMANDS) trial assessing the safety & efficacy of Reblozyl vs epoetin alfa to treat patients (n=363) with transfusion-dependent anemia due to very low-, low- or intermediate-risk (IPSS-R) myelodysplastic syndromes (MDS)
The primary analysis in the ITT population, as of Mar 31, 2023, showed that 60.4% vs 34.8% of patients reached RBC-TI for 12wks. with a mean Hb increase ≥1.5 g/dL during the first 24wks. and 74.2% vs 53% of them achieved HI-E increase of at least 8wks.
Furthermore, 68.1% vs 48.6% reached RBC-TI of at least 12wks. and DoR of 128.1wks. vs 89.7wks. was observed in patients attaining TI for at least 12wks. The safety profile was consistent with the prior MDS evaluations
Ref: BMS | Image: BMS
Related News:- BMS’ Reblozyl Gains CHMP’s Positive Opinion to Treat Transfusion-Dependent Anemia Due to Myelodysplastic Syndrome (MDS)
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