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FDA Approves Isatuximab for Relapsed/Refractory Multiple Myeloma

Rye Brook, N.Y., April 20, 2021 - The U.S. Food and Drug Administration (FDA) approved isatuximab (Sarclisa) in combination with carfilzomib and dexamethasone to treat adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.

This is the second FDA approval for multiple myeloma in 2021 alone and is promising news in the fight against myeloma. The FDA approval is based on data from a Phase 3 study that enrolled 302 patients with relapsed multiple myeloma. In the study, the combination therapy reduced the risk of disease progression or death by 45%. At the time of analysis, overall survival (OS) data was still immature. The most common adverse events (AEs) were upper respiratory tract infection, infusion-related reactions, and fatigue.

Myeloma is the second most common blood cancer in the U.S. Despite advances in treatment in recent years, the five-year relative survival rate for myeloma is 53.7%, which means there is still more work to be done.

Research funded by The Leukemia & Lymphoma Society helped support the understanding of CD38 as a target in myeloma, which laid foundational research to helped advance isatuximab, which is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells. In fact, LLS has played a role in 85% of all blood cancer FDA approvals since 2017.

Myeloma is among LLS’s primary research initiatives with more than 30 active projects – over a $40 million commitment – focused on laboratory and clinical research. They include world-class researchers at Dana Farber Cancer Institute, MD Anderson Cancer Center and the University of Pennsylvania who are looking at ways to provide safe and effective targeted therapies and to adapt CAR T- cell immunotherapy for patients with multiple myeloma. LLS Specialized Center of Research (SCOR) grantee, Robert Z. Orlowski, MD, PhD, MD Anderson Cancer Center, is currently examining new therapies for myeloma including research to determine if isatuximab can help treat patients with smoldering multiple myeloma.

Today’s approval of isatuximab is an encouraging advancement for multiple myeloma patients. LLS is determined to change the future of myeloma treatment and care. Our vision centers on driving new breakthroughs and cures, helping all myeloma patients access the care they need to survive and thrive, and addressing healthcare disparities that disproportionately impact underserved populations.

About The Leukemia & Lymphoma Society

The Leukemia & Lymphoma Society® (LLS) is a global leader in the fight against cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care. 

Founded in 1949 and headquartered in Rye Brook, NY, LLS has regions throughout the United States and Canada. To learn more, visit Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m. ET.

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