BMS Reports the EC’s Expanded Approval of Reblozyl as a 1L Treatment of Transfusion-Dependent Anemia Due to Myelodysplastic Syndromes
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- 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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
