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LLS Experts: CAR T-therapy Benefits Outweigh Risks for Appropriate Patients

Rye Brook, N.Y., February 8, 2024 — The Leukemia & Lymphoma Society (LLS) has been closely monitoring reports from the U.S. Food and Drug Administration (FDA) and published data about the risk of therapy-related secondary cancers in people treated with CAR T-immunotherapy.

LLS is aligned with the FDA that the benefits of CAR-T outweigh its risks for patients in whom CAR T-immunotherapy treatment is indicated and recommended by their oncology care team.    

CAR T-immunotherapy, which became available in 2017, uses a patient’s own immune system to fight cancer. With six CAR-T treatments currently available, this breakthrough immunotherapy is saving and extending the lives of adults with forms of multiple myeloma and lymphoma, as well as both adults and children with forms of leukemia.  

Most patients who receive CAR T-immunotherapy are facing a poor prognosis and have limited or no other suitable treatment options. CAR-T can be effective even when all other treatments have failed. 

Based on reports to the FDA,i it appears that CAR-T, like many cancer treatments — including chemotherapy and radiation — carries a very small risk for development of therapy-related T-cell cancer. As of December 31, 2023, the FDA is evaluating 22 reports of T-cell cancer among more than 27,000 patients previously treated with CAR-T in the U.S. Consistent with this, investigators at the University of Pennsylvania have found only one T-cell lymphoma among the 500 patients treated with CAR T at their institution.ii 

FDA evaluation of the cases is ongoing, but at least three cases appear to be related to previous CAR-T treatment. T-cell cancers have been reported after treatment with all but one CAR-T product. At this time, there is no indication that any CAR-T product carries more or less risk than any other. 

These reports to the FDA show that the regulatory system is working as intended, making lifesaving treatments available to patients, while continuing to monitor for rare treatment-related outcomes. FDA required reporting of secondary cancer cases as a condition of approval for all CAR T-cell therapies. 

LLS will continue to monitor the data and will provide updates as needed. Patients currently receiving or considering CAR T-immunotherapy should discuss their concerns with their treatment team.  

For more information on a blood cancer diagnosis or treatments like CAR-T, you can speak one-on-one with an LLS Information Specialist by calling 1-800-955-4572 or by clicking here. LLS Information Specialists are highly trained oncology social workers and nurses who can assist blood cancer patients and families by providing accurate, up-to-date information and support resources at no cost. 


[i] Verdun N and Marks P. Secondary cancers after chimeric antigen receptor T-cell therapy. N Engl J Med. 2024 Jan 24. doi:10.1056/NEJM2400209. 
[ii] Ghilardi G, Fraietta JA, Gerson JN, et al. T-cell lymphoma and secondary primary malignancy risk after commercial CAR T-cell therapy. Nat Med. 2024 Jan 24. doi:10.1038/s41591-024-02826-w.