U.S. License Holder:
Celgene Corp.
Date of License:
November-08-2019
Last Update:
Nov-15-2024
FDA-Approved Indications
REBLOZYL (luspatercept-aamt) is an erythroid maturation agent indicated for the treatment of:
Anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions;
Anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions;
Anemia failing an erythropoiesis stimulating agent and requiring 2 or more RBC units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic / myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
