FDA Issues Safety Communication for BCMA- or CD19-Directed Autologous CAR T-Cell Immunotherapies While Investigating Serious Risk for T-Cell Malignancy

November 29, 2023

On November 28, 2023, the U.S. Food and Drug Administration (FDA) issued a safety communication (https://www.fda.gov/safety/medical-product-safety-information/bcma-directed-or-cd19-directed-autologous-chimeric-antigen-receptor-car-t-cell-immunotherapies-fda) to patients and healthcare professionals regarding BCMA- or CD19-directed autologous CAR T-cell immunotherapies. The agency said it received reports of T-cell malignancies, including CAR-positive lymphoma, in patients who received treatment with those products. The reports came from clinical trials and postmarketing adverse event data sources.

FDA update

FDA said (https://www.fda.gov/safety/medical-product-safety-information/bcma-directed-or-cd19-directed-autologous-chimeric-antigen-receptor-car-t-cell-immunotherapies-fda) that the risk is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies. T-cell malignancies have occurred in patients treated with several products in the class. At the time of the communication, the currently approved products are:

Although the products’ overall benefits continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T-cell malignancy with serious outcomes, including hospitalization and death, and evaluating the need for regulatory action.

“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 for approved BCMA-directed and CD19-directed genetically modified autologous T cell immunotherapies,” FDA said (https://www.fda.gov/safety/medical-product-safety-information/bcma-directed-or-cd19-directed-autologous-chimeric-antigen-receptor-car-t-cell-immunotherapies-fda). “The initial approvals of these products included postmarketing requirements under Section 505(o) of the Federal Food, Drug, and Cosmetic Act 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.”

FDA recommended (https://www.fda.gov/safety/medical-product-safety-information/bcma-directed-or-cd19-directed-autologous-chimeric-antigen-receptor-car-t-cell-immunotherapies-fda) that:

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