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Tuesday, 11/28/2023 4:15:16 PM

Tuesday, November 28, 2023 4:15:16 PM

Post# of 34625
The FDA on Tuesday said it has launched an investigation into reports about serious risk of T-cell malignancies with CAR-T therapies, including CAR-positive lymphoma, and is considering whether it needs to step in. The agency suggested that this risk applies to all currently approved BCMA- and CD19-directed autologous CAR-T immunotherapies, noting that T-cell malignancies have occurred in patients treated with "several products."
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