Skip to main content

FDA Approves a New Immune-Based Treatment Option for People with Mantle Cell Lymphoma

The FDA continues to expand availability of breakthrough CAR T-cell immunotherapy to benefit more blood cancer patients

Rye Brook, N.Y., May 31, 2024 – The U.S. Food and Drug Administration (FDA) yesterday approved the chimeric antigen receptor T-cell (CAR-T) therapy lisocabtagene maraleucel (liso-cel, Breyanzi®) to treat certain adults with mantle cell lymphoma. 

“This marks the third expansion of liso-cel’s availability for blood cancer patients in as many months,” says Lee Greenberger, Ph.D., The Leukemia & Lymphoma Society’s (LLS) Chief Scientific Officer. “Each new approval marks important progress in making CAR T-cell immunotherapy available to more patients.” 

Last week the FDA approved liso-cel in certain adults with follicular lymphoma, and in March it became the first ever CAR T-cell therapy approved for certain adults with chronic lymphocytic leukemia. It was previously approved for treatment of large B-cell lymphoma. 

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

This approval marks the 17th for CAR T-cell therapy since the first one in 2017.  

Liso-cel is one of six CAR T-cell products approved for use in the United States. All are usually administered as “one and done” treatments that train a patient’s immune system as a precision fighting mechanism against their specific blood cancer type.  

“While this approval is great news for patients, there is still so much more we can do to improve CAR-T and other forms of immunotherapy,” says Greenberger.  

LLS currently has $93 million in funding commitments for 75 research projects looking at ways to make these treatments safer, more effective, quicker to use, and available to even more patients. 

Response to Treatment  

The FDA based its decision on study findings that showed that 85.3% of patients with mantle cell lymphoma receiving liso-cel responded to therapy, with 67.6% having a complete response, meaning their cancer could not be detected. 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. Findings showed that 51.4% of patients continued to respond for 12 months and 38.8% were still responding at 18 months. 

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