Kerri Fitzgerald

DocwireNews

The U.S. Food and Drug Administration approved Reblozyl&reg; (luspatercept-aamt), the first and only erythroid maturation agent (EMA), for the treatment of <a href="https://www.docwirenews.com/abstracts/hem-onc-abstracts/prevalence-diabetic-adults-anemia/">anemia</a>&nbsp;in patients failing an erythropoiesis stimulating agent (ESA) and requiring two or more red blood cell (RBC) units over eight weeks. The treatment is indicated for adults with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis.&nbsp;Luspatercept-aamt is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of <a href="https://www.docwirenews.com/nephtimes/ckd-anemia-burden-treatment/">anemia</a>. This is the first treatment in more than a decade indicated for MDS.The approval was based on results of the pivotal randomized, double-blind, placebo-controlled, multicenter, phase III MEDALIST trial&nbsp;that included 229 patients with very low-, low-, and intermediate-risk non-del(5q) MDS-RS who received luspatercept-aamt 1.0 mg/kg with titration up to 1.75 mg/kg if needed (n=153) or placebo (n=76). All patients were RBC transfusion-dependent and were refractory or intolerant to a prior ESA or were unlikely to respond to an ESA due to endogenous serum erythropoietin &ge;200 U/L.<h2>Improved independence from RBC transfusions with luspatercept-aamt</h2>A significantly greater proportion of patients receiving&nbsp;luspatercept-aamt (38%) achieved independence from RBC transfusions (primary endpoint) for at least eight weeks during the first 24 weeks of treatment compared with those receiving placebo (13%; P&lt;0.001). A significantly greater proportion of patients receiving&nbsp;luspatercept-aamt achieved at least 12 weeks of independence from transfusions within the first 24 (28% vs. 8%) and 48 (33% vs. 12%) weeks of the study compared with placebo.Most treatment-related adverse events (AEs) were grade 1/2. Grade 3/4 AEs occurred in 42.5% of patients receiving luspatercept-aamt&nbsp;and 44.7% of patients receiving placebo. The most common any-grade AEs were fatigue, musculoskeletal pain, dizziness, diarrhea, dyspnea, nausea, hypersensitivity reactions, headache, and upper respiratory tract infection. The incidence of AEs decreased over time.Full study results were published in <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa1908892">The New England Journal of Medicine</a>.

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Latest News

FDA Approves First Erythroid Maturation Agent to Treat Anemia in Patients With Myelodysplastic Syndromes

The U.S. Food and Drug Administration approved Reblozyl® (luspatercept-aamt), the first and only erythroid maturation agent (EMA), for the treatment of anemia in patients ...

FDA Approves First Erythroid Maturation Agent to Treat Anemia in Patients with Myelodysplastic

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