BMS’ Reblozyl (luspatercept-aamt) Receives the US FDA’s Approval as 1L Treatment of Anemia in Adults with Lower-Risk Myelodysplastic Syndromes
Shots:
- The US FDA has approved Reblozyl for anemia without prior ESA-naïve use in adult patients with very low to intermediate-risk MDS who may require regular RBC transfusions. Reblozyl is being developed & commercialized through a collaboration with Merck
- The approval was based on interim results from a P-III trial (COMMANDS) evaluating Reblozyl vs epoetin alfa in 363 patients which demonstrated superior efficacy of concurrent RBC transfusion independence & Hb increase over epoetin alfa regardless of ring sideroblast status
- 58.5% vs 31.2% achieved the 1EPs of RBC-TI of 12wks. with concurrent mean Hb increase of 1.5g/dL within the first 24wks., HI-E increase (74.1% vs 51.3%) at 8wks., RBC-TI (47.6% vs 29.2%) within the first 24wks., RBC-TI (66.7% vs 46.1%) at 12wks. & showed durable responses with 2.5yrs. of median RBC-TI ≥12wks. The results were published in The Lancet
Ref: Businesswire | Image: BMS
Related News:- BMS Receives EMA’s CHMP Positive Opinion Recommending Approval of Opdivo (nivolumab) for Completely Resected Stage IIB or IIC Melanoma
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Tags
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
