November 30, 2023
The Food and Drug Administration is investigating the risk of T-cell malignancies, including chimeric antigen receptor (CAR)-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T-cell immunotherapies, the agency announced Tuesday. The risk of T-cell malignancy with serious outcomes, including hospitalization and death, in patients treated with several products in this class is under investigation, and the agency is evaluating the need for regulatory action.
FDA has determined that the risk of T-cell malignancies applies to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies:
FDA emphasized that the overall benefits of these treatments continue to outweigh potential risks for their approved uses. However, the agency noted that the potential risk of developing secondary malignancies is labeled as a class warning in the prescribing information for each of these therapies. FDA’s initial approval of these products mandated 15-year-long follow-up safety studies to assess long-term safety and risks post-treatment.
FDA recommends that patients and clinical trial participants who receive these treatments should be monitored for new malignancies for the rest of their lives. If a new malignancy occurs following treatment, health care providers should 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. Clinicians should also report suspected adverse events including T cell malignancies to FDA.
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