FDA Orders Safety Changes to 5 CAR-T Labels

After evaluating an identified risk of T-cell malignancy following BCMA-directed or CD-19-directed autologous chimeric antigen receptor (CAR) T-cell immunotherapies, FDA has ordered safety labeling changes for five of the products. The agency had announced on 11/28/2023 that it had received reports of T-cell malignancies, including CAR-positive lymphoma, in patients who received treatment with six CAR T-cell immunotherapies.

The order for safety labeling changes applies to five of the six drugs that were evaluated — Bristol-Myers Squibb’s Abecma (idecabtagene vicleucel), Bristol-Myers Squibb’s Breyanzi (lisocabtagene maraleucel), Janssen’s Carvykti (ciltacabtagene autoleucel), Novartis’ Kymriah (tisagenlecleucel), and Kite’s Yescarta (axicabtagene ciloleucel). The sixth immunotherapy that was evaluated was Kite’s Tecartus (brexucabtagene autoleucel). FDA did not refer to it in the announcement of labeling changes.