FDA issues black box warning for CAR-T therapies

Jan. 24, 2024

Earlier this week, the FDA issued black box warnings on BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, citing a heightened risk of T-cell malignancies, including severe outcomes like hospitalization and death.

Consequently, the FDA has mandated the inclusion of new safety information in the labeling for all such therapies, including popular ones like Kite's Yescarta, BMS' Abecma, Juno's Breyanzi and Novartis' Kymriah.

Labeling changes involve the addition of boxed warnings, updates to warnings and precautions, and enhanced information in adverse reactions, patient counseling, and medication guide sections. Drugmakers have been given a 30-day window to submit proposed changes, failing which enforcement actions may be taken.

Back in November of last year, the FDA received reports of T-cell malignancies, including CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR-T immunotherapies. 

Despite the new warnings, the agency has stated that the overall benefits of these therapies still outweighed potential risks.