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FDA Approves First CAR T-Cell Therapy for Chronic Lymphocytic Leukemia

This approval extends the landmark immunotherapy treatment to adults with the most common form of leukemia. 

Rye Brook, N.Y., March 19, 2024 – The U.S. Food and Drug Administration approved the CAR T-cell therapy lisocabtagene maraleucel (liso-cel, Breyanzi®) on March 14, 2024, for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has not responded to previous treatments.  

CAR T-cell therapy is a personalized option that arms a patient’s own immune system with the tools it needs to fight cancer. With this latest approval, six different CAR T-cell therapies are now approved to treat ten different types of blood cancer.  

“This CAR-T milestone is very meaningful to all of us at The Leukemia & Lymphoma Society because LLS scientists were among the first to recognize the treatment’s potential and to put its substantial financial backing into research that led the way to where we are today,” says Lee Greenberger, Ph.D., LLS Chief Scientific Officer. 

Liso-cel is available to patients whose CLL or SLL has returned or worsened despite at least two previous treatments, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. The treatment was approved in 2021 to treat several forms of large B-cell lymphoma. 

Thanks to the ongoing discovery of new therapies, both overall survival time and how long CLL patients live without their disease progressing have been increasing for years. But this generally means patients need to stay on therapy indefinitely, stopping when their disease progresses or when treatment side effects and toxicity become unacceptable and CLL and SLL remain incurable. 

Typically, CAR T-cell therapies are given just once. In some cases, the treatment has led to long-term remissions and even cures in some patients who were facing a very poor prognosis with limited or even no other treatment options.  

“We are hopeful that some patients with CLL who have failed our best therapies to date will receive long-term benefit from liso-cel,” says Dr. Greenberger. 

LLS is Focused on Leading the Charge of Next Generation Treatments 

While CAR T-cell therapies are revolutionary, they have limitations. LLS is investing in research examining many of these issues, such as why CAR T-cell therapies work in some people and not others and why some people do well on the therapy only to have their cancer become resistant to it quickly.  

LLS is also investing in research into next generation immunotherapy approaches that use not just T cells, but other immune cells, like natural killer and macrophages to make CAR therapy longer lasting and useful in more types of blood cancer. LLS research support is also focused on ways to make these treatments less expensive and quicker for patients to receive.  

If you or a loved one need personalized disease, treatment or support information, you can contact one of our Information Specialists: 

Media Contact: 
Ryan McDonald 
Senior Manager, Medical and Science Communications