This approval marks a step in the right direction toward bettering a patient’s quality of life, says LLS’s Chief Scientific Officer Lee Greenberger, Ph.D.
Rye Brook, N.Y., August 29, 2023 – The U.S. Food and Drug Administration (FDA) on Monday approved luspatercept-aamt (Reblozyl®) to treat anemia in adults with very low- to intermediate-risk myelodysplastic syndromes who may need routine red blood cell (RBC) transfusions.
This approval expands on a previous authorization of luspatercept for use in adults with this condition whose anemia failed to respond to a treatment designed to stimulate production of red blood cells and who required two or more red blood cell transfusions over eight weeks. The new approval was based on findings from the phase 3 COMMANDs study, which showed that treatment with luspatercept improved RBC transfusion independence and hemoglobin values compared with epoetin alfa (Procrit).
“The FDA’s decision to approve an additional indication of luspatercept is welcomed news for a group of patients with myelodysplastic syndromes who are living with anemia, a disorder that can cause significant side effects,” said Lee Greenberger, Ph.D., LLS’s Chief Scientific Officer.
People with anemia don’t have enough red blood cells to carry oxygen to the body’s tissues. They can experience a range of debilitating side effects, including fatigue, shortness of breath, and irregular heartbeat.
“At LLS, we are not only dedicated to curing leukemia, lymphoma, myeloma, and other blood cancers, but we are also determined to improve the quality of life among patients living day-to-day with a blood cancer,” Dr. Greenberger said. “This approval is another step in the right direction toward bettering a patient’s quality of life.”
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