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FDA’s Latest CAR T-Cell Therapy Approval a ‘Significant Milestone’ for Blood Cancer Patients

Researchers at The Leukemia & Lymphoma Society were some of the first to recognize and champion the use of a patient’s immune system to attack their blood cancer, and our research support to develop new immunotherapies continues to this day.  

Rye Brook, N.Y., May 21, 2024 – The U.S. Food and Drug Administration (FDA) recently approved the chimeric antigen receptor T-cell (CAR-T) therapy lisocabtagene maraleucel (liso-cel, Breyanzi®) for adults with follicular lymphoma that has not responded to two or more prior lines of treatment. 

“Follicular lymphoma becomes increasingly more difficult to treat as the disease progresses,” says Lee Greenberger, Ph.D., The Leukemia & Lymphoma Society’s (LLS) Chief Scientific Officer. “The more options physicians have to keep a patient’s disease in remission for longer periods of time, the better.” 

Liso-cel was first approved in 2021 to treat adults with certain forms of large B-cell lymphoma (LBCL). Then, in 2022, the FDA approved liso-cel to treat adults with LBCL whose cancer returned or worsened within a year of receiving first-line chemotherapy. Liso-cel was also recently approved to treat relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. 

Read more about how CAR T-cell therapy harnesses a patient’s immune system to attack their cancer 

“This is a significant milestone for blood cancer patients,” says Dr. Greenberger. “Within seven years, we have seen 16 CAR-T approvals with 6 different CAR-T products. More than ever, patients now have the option to receive CAR-T therapy that may lead to long-term remission.”  

LLS was among the earliest financial supporters of CAR T-cell therapy research beginning in the 1990s and continues to support the development of next-generation CAR-T therapies.  

“LLS provided grants to many of the first people to recognize the importance of harnessing the immune system to attack blood cancer and were sure to champion it,” says Dr. Greenberger. “Thirty years later, our support continues to fuel the latest research into new immunotherapies.”  

Responses to Treatment 

The FDA based its decision on study findings that showed that 95.7% of patients receiving treatment with the CAR T-cell therapy liso-cel achieved a partial or complete response to therapy, meaning their cancer has partly or completely disappeared. Of note, a complete response does not always mean the cancer has been cured. 

Most patients’ disease responded to liso-cel within the first month of treatment. A median duration of response was not reached among patients enrolled in the clinical trial. This means that more than half of the patients continued to respond to the one-time treatment at the time of last data review.  

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