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# Boxed Warning Ordered on CAR T-Cell Therapies
- URL: https://www.fdaweb.com/boxed-warning-ordered-on-car-t-cell-therapies/
- Published: 2024-04-19T12:00:00.000Z
- Updated: 2026-09-14T14:28:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156813

FDA has [ordered](https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-boxed-warning-t-cell-malignancies-following-treatment-bcma-directed-or-cd19-directed?ref=fdaweb.com) a Boxed Warning to highlight the serious risk of T cell malignancies following administration of BCMA-directed or CD-19-directed autologous chimeric antigen receptor (CAR) T-cell immunotherapies. The increased warning follows a 11/2023-[posted](https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-investigating-serious-risk-t-cell-malignancy-following-bcma-directed-or-cd19-directed-autologous?ref=fdaweb.com) safety communication about reports of T cell malignancies received from clinical trials and postmarketing adverse event data sources.

The Boxed Warning order applies to all six CAR T-cell therapies 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), Kite’s Yescarta (axicabtagene ciloleucel) and Kite’s Tecartus (brexucabtagene autoleucel). Additionally, the agency notes that it has required related updates to other sections of the label (Warnings and Precautions, Postmarketing Experience, Patient Counseling Information and Medication Guide) as part of its ongoing safety evaluation.

“Patients and clinical trial participants receiving treatment with these products should be monitored life-long for secondary malignancies,” the agency update says.