The U.S. Food and Drug Administration (FDA) issued a warning about the risk of T-cell malignancies in patients who have received BCMA- or CD19-directed autologous chimeric antigen receptor (CAR) T-cell immunotherapies.
The warning followed the receipt of reports from clinical trials and post-marketing adverse event sources detailing T-cell malignancy occurrences in this patient population.
The FDA noted the risk is applicable to all currently approved treatments in this class including:
- idecabtagene vicleucel
- lisocabtagene maraleucel
- ciltacabtagene autoleucel
- tisagenlecleucel
- brexucabtagene autoleucel
- axicabtagene ciloleucel
A press release from the FDA noted that the benefits of these therapies still outweigh this risk, but the need for further action is being evaluated.
“Patients and clinical trial participants receiving treatment with these products should be monitored life-long for new malignancies,” the press release said. “In the event that a new malignancy occurs following treatment with these products, contact the manufacturer to report the event and obtain instructions on collection of patient samples for testing for the presence of the CAR transgene.”
Source: FDA, November 28, 2023.
