Shots:
- The positive opinion was supported by the P-III (COMMANDS) study assessing the safety & efficacy of Reblozyl (1.0mg/kg, titration ~1.75mg/kg, Q3W) vs epoetin alfa (450 IU/kg, titration ~1050IU/kg, QW) for ≥24 wks. to treat transfusion-dependent anemia due to very low-, low- or intermediate-risk (IPSS-R) MDS in patients naïve to erythropoiesis-stimulating agent
- The data, as of Mar 2023, in patients (n=363) depicted RBC-TI of at least 12wks. in 60.4% vs 34.8% with mean Hb increase of ~1.5 g/dL in first 24wks., 74.2% vs 53% had HI-E increase of at least 8wks., 68.1% vs 48.6% experienced RBC-TI of at least 12wks.& a DoR of 128.1wks. vs 89.7wks.
- The safety profile was consistent with the prior MDS programs
Ref: BMS | Image:BMS | Press Release
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