> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Malignancy Events with CAR T-Cell Therapies: FDA
- URL: https://www.fdaweb.com/malignancy-events-with-car-t-cell-therapies-fda/
- Published: 2023-11-28T12:00:00.000Z
- Updated: 2026-09-14T14:17:06.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155869

FDA says it is investigating an identified risk of T-cell malignancy following BCMA-directed or CD19-directed autologous chimeric antigen receptor (CAR) T-cell immunotherapies, and is evaluating the need for regulatory action. The agency says it has received reports of T-cell malignancies, including CAR-positive lymphoma, in patients who received treatment with the CAR T-cell immunotherapies. Reports were received from clinical trials and postmarketing adverse event data sources. “Patients and clinical trial participants receiving treatment with these products should be monitored life-long for new malignancies,” FDA says.

“FDA has determined that the risk of T-cell malignancies is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies,” a just-posted [safety alert](https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-investigating-serious-risk-t-cell-malignancy-following-bcma-directed-or-cd19-directed-autologous?ref=fdaweb.com) says. “T-cell malignancies have occurred in patients treated with several products in the class.” Approved products in this class include the following:

- Abecma (idecabtagene vicleucel)
- Breyanzi (lisocabtagene maraleucel)
- Carvykti (ciltacabtagene autoleucel)
- Kymriah (tisagenlecleucel)
- Tecartus (brexucabtagene autoleucel)
- Yescarta (axicabtagene ciloleucel)

While the investigation is ongoing, FDA says the overall benefits of the products continue to outweigh their potential risks for their approved uses. “As with all gene therapy products with integrating vectors (lentiviral or retroviral vectors), the potential risk of developing secondary malignancies is labeled as a class warning in the U.S. prescribing information (USPIs) for approved BCMA-directed and CD19-directed genetically modified autologous T cell immunotherapies,” FDA says. The initial approvals of CAR-T therapies also included postmarketing requirements for sponsors to conduct 15-year long-term follow-up observational safety studies “to assess the long-term safety and the risk of secondary malignancies occurring after treatment,” it notes.