T-cell Malignancy From CAR-T Cell Immunotherapies Gets FDA Investigation
After receiving reports of T-cell malignancies in patients who received treatment with BCMA- or CD19-directed autologous CAR-T cell immunotherapies, the agency has announced an investigation into the issue and is evaluating the need for regulatory action.
According to the agency, reports from clinical trials and postmarketing adverse events, the risk — which includes chimeric antigen receptor CAR-positive lymphoma — is applicable to all currently approved B-cell maturation antigen (BCMA) directed and CD19-directed genetically modified autologous CAR-T cell immunotherapies.
Although the agency said the overall benefits of these products continue to outweigh their risks, they noted that all gene therapy products with integrating vectors (lentiviral or retroviral vectors) pose the potential risk of developing secondary malignancies.
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