FDA updates on CAR-T cell therapies label changes

The US Food and Drug Administration (FDA) has posted a safety communication to inform the public and healthcare providers that the agency has required and approved labeling changes to the US Prescribing Information (USPI) for all licensed BCMA-directed and CD19-directed genetically modified autologous CAR-T cell immunotherapies.

These completed changes follow a safety communication posted by the FDA in November 2023, and reflect requirements detailed in notification letters  issued by the FDA in January 2024, to all manufacturers of the products in this class necessitating an update to the Boxed Warning on the package insert to include new safety information on the serious risk of T cell malignancies, with serious outcomes, including hospitalization and death.

The FDA also required related safety labeling changes to other sections of the USPI: Warnings and Precautions, Post-marketing Experience, Patient Counseling Information and Medication Guide.