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Shaji K. Kumar, MD

Prashant Kapoor, MD, FACP


FDA Calls for New Boxed Warning on All CAR T-Cell Therapies

By: JNCCN 360 Staff
Posted: Thursday, January 25, 2024

On January 19, the U.S. Food & Drug Administration (FDA) issued safety labeling change notification letters to all manufacturers of licensed B-cell maturation antigen (BCMA)-directed and CD19-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell immunotherapies requiring a revision to the package insert because of the risk of T-cell malignancies, with serious outcomes (including hospitalization and death). The letters notify manufacturers of each such licensed product to update the package insert to include available information related to the risks and to update the medication guide for these products to identify the possibility of the increased risk of developing cancers (including certain types of cancers of the immune system).

The FDA considers the serious risk of T-cell malignancy to be applicable to all BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies. Six BCMA- or CD19-directed CAR T-cell agents are approved for the treatment of hematologic malignancies. Two are indicated for use in multiple myeloma: idecabtagene vicleucel (Abecma) and ciltacabtagene autoleucel (Carvykti).

In November 2023, the FDA posted a safety communication to provide information related to the receipt of reports of T-cell malignancies, including CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T-cell immunotherapies. Reports were received from clinical trials and/or postmarketing adverse event data sources. Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, the FDA continues to investigate the identified risk of T-cell malignancy.

Patients and clinical trial participants receiving treatment with these products should be monitored for new malignancies. In the event a new malignancy occurs after treatment with these products, clinicians are encouraged to contact the manufacturer to report the event and obtain instructions on collection of patient samples for testing for the presence of CAR transgene.

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