In head-to-head study, Reblozyl nearly doubled the percent of patients achieving primary endpoint of concurrent transfusion independence and hemoglobin increase vs. epoetin alfa.
The FDA has approved Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) to treat anemia in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS). It is indicated as first-line therapy for patients who have not received erythropoiesis stimulating agents (ESA).
Myelodysplastic syndromes (MDS) are a group of blood cancers characterized by ineffective production of healthy red blood cells, white blood cells and platelets. This can lead to anemia and frequent or severe infections. People with MDS who develop anemia often require blood transfusions.
Reblozy promotes late-stage red blood cell maturation and is also approved to treat anemia in adult patients with beta thalassemia who require regular red blood cell transfusions and in patients who have already received and failed treatment with erythropoiesis stimulating agents. The cost for Reblozyl 25 mg powder is around $4,011 for a supply of one injection, and $12,013.37 for 75 mg powder for one injection, according to Drugs.com. Reblozyl is being developed and commercialized through a global collaboration with Merck as of November 2021.
“For patients with lower-risk MDS, current standard therapies, including ESAs, have provided limited benefit in controlling anemia with only one in three patients responding for a duration of six to 18 months,” Guillermo Garcia-Manero, M.D., lead investigator and chief of the Section of Myelodysplastic Syndromes at The University of Texas MD Anderson Cancer Center, said in a press release.
This expanded indication is based on interim results from the phase 3 COMMANDS trial, in which Reblozyl demonstrated superior efficacy of concurrent red blood cell transfusion independence (RBC-TI) and hemoglobin (Hb) increase compared with epoetin alfa, an ESA. In the trial, esults showed 58.5% of 86 patients treated with Reblozyl vs. 31.2% of the 48 patients treated with epoetin alfa achieved the primary endpoint of RBC-TI of at least 12 weeks. The most common adverse reactions were diarrhea, fatigue, hypertension, peripheral edema, nausea, and dyspnea.
Results from the COMMANDS study were featured in June as part of the press program at the American Society of Clinical Oncology (ASCO) Annual Meeting and plenary session at the European Hematology Association (EHA) Congress, with publication in The Lancet in June 2023.