FDA Warns on CAR-Ts, but Benefits Outweigh Risks for Now

Feb 08
Feb 08, 2024

A couple of months after the FDA revealed that it was investigating the risks of chimeric antigen receptor T cell (CAR-T) immunotherapies, the agency is seeking updated language in their labels warning about those risks. However, the fact that the FDA is allowing the therapies to remain on the market suggests that their overall benefits outweigh their potential risks, says one industry expert.

In late November, the FDA revealed that it was investigating the risks of CAR-T therapies following reports of T cell malignancies in people who had undergone treatment with the agents. Less than two months later, the agency issued safety labeling change notification letters to the six available B cell maturation antigen (BCMA)-directed or CD-19 directed autologous CAR-Ts, which cover a range of hematologic cancers:
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Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.