Pharmaceutical Executive November 29, 2023
The FDA will investigate all currently approved CAR T-cell treatments, as well as BCMA-directed and CD19-directed genetically modified autologous CAR T-cell therapies, for the risk of secondary T-cell malignancies.
The FDA has announced plans to launch an investigation into the potential risk of secondary cancer associated with the use of chimeric antigen receptor (CAR) T-cell therapies. The investigation was prompted following reports from clinical trials and tracking of postmarketing adverse events for T-cell malignancies, including CAR-positive lymphoma, among patients administered BCMA- or CD19-directed CAR-T cell immunotherapies.1
“Although the overall benefits of these products 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,...
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