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FDA Warns of T-Cell Malignancy Risk Following Autologous CAR T-Cell Therapy

NEW YORK – The US Food and Drug Administration on Wednesday warned that patients receiving autologous CAR T-cell therapies targeting the B-cell maturation antigen (BCMA) and CD19 may be at higher risk of developing new T-cell malignancies.

In a safety warning, the FDA said there have been reports of T-cell cancers including CAR-positive lymphoma among patients who received these BCMA/CD19-directed autologous cell treatments within clinical trials and in the post-market setting. The cell therapies flagged by the FDA include Bristol Myers Squibb's Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel); Janssen's Carvykti (ciltacabtagene autoleucel); Novartis' Kymriah (tisagenlecleucel); and Gilead Sciences' Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel).

The US prescribing labels for these therapies already mention the potential risk of secondary cancers. Although the FDA said the benefits of these therapies continue to outweigh the risks, it is investigating the potential for serious adverse outcomes with these CAR T-cell therapies, such as hospitalization or death, and is assessing if it needs to take regulatory action to limit these risks.

In the meantime, the FDA said patients and clinical trial participants should be monitored for these malignancies, and if they do occur after autologous CAR T-cell therapy, these cases should be reported to the agency. The agency further said that patients and their doctors should follow instructions from treatment manufacturers for collecting patient samples and testing for CAR transgenes.