CAR-T Warning for Secondary Malignancies: Warranted or Not?
Oncology/Hematology
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Leukemia
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FDA boxed warning led to multiple studies on the issue in 2024
by
Mike Bassett, Staff Writer, MedPage Today
January 5, 2025
Early in 2024, we reported on the FDA's call for new boxed warnings on the labeling of all approved chimeric antigen receptor (CAR) T-cell therapies for the potential risk for secondary T-cell malignancies. In this report, we follow up on what has happened since.
In January 2024, the FDA mandated new boxed warnings on approved B-cell maturation antigen (BCMA)- or CD19-di...