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FDA Warning on CAR-T Cell Therapy

On Nov. 28, 2024, FDA issued a safety alert regarding CAR-T cell immunotherapies; noting reports of T-cell malignancies (CAR-positive lymphoma) arising in patients treated with BCMA- or CD19-directed autologous CAR T cell immunotherapies and that if there is a risk, this only applies to currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies. 

They are investigating T-cell malignancies occurring in patients receiving this class of therapy; specifically with the use of these products:

Abecma (idecabtagene vicleucel)

Breyanzi (lisocabtagene maraleucel)

Carvykti (ciltacabtagene autoleucel)

Kymriah (tisagenlecleucel)

Tecartus (brexucabtagene autoleucel)

Yescarta (axicabtagene ciloleucel)

Currently, the overall benefits of these products continue to outweigh their potential risks; the FDA is investigating the identified risk of T cell malignancy with serious outcomes (including hospitalization and death) and is considering the need for regulatory action.

As with all gene therapy products with integrating vectors (lentiviral or retroviral vectors), the current product labels for these drugs do list a warning for developing secondary malignancies (class warning) related to the use of BCMA-directed and CD19-directed genetically modified autologous T cell immunotherapies.  

Currently, CAR T-cell therapy has been used in the treatment of leukemia, lymphoma, and myeloma, largely in patients who are refractory to traditional treatments, like chemotherapy, radiation, and surgery.  CAR-T cell therapy is being investigated in patients with serious lupus and other autoimmune disorders.

Patients and clinical trial participants receiving treatment with these products should be monitored life-long for new malignancies.  In the event that a new malignancy occurs following treatment with these products, contact the manufacturer to report the event and obtain instructions on collection of patient samples for testing for the presence of the Chimeric Antigen Receptor (CAR) transgene.

To report suspected adverse events including T cell malignancies, contact the FDA at 1-800-FDA-1088 or




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The author has no conflicts of interest to disclose related to this subject