FDA orders new info warnings on CAR-T therapies

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Following its review of reports of T-cell malignancies associated with the administration of six B-cell maturation- or B-lymphocyte antigen CD19-directed autologous chimeric antigen receptor T-cell (CAR-T) immunotherapies, the U.S. Food and Drug Administration (FDA) has instructed the manufacturers to include boxed warnings in the prescribing information for the therapeutics.

The FDA began investigating the claims of new blood cancers occurring during CAR-T therapy treatment in November; the agency sent letters dated January 19 and January 23 to the manufacturers of Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, and Yescarta directing what new warning information is to be included in the prescribing information, specifying in which section each warning should be added.

Researchers and advocates for cell therapy point out that these T-cell malignancy cases are very rare: There have been only 20 such cases reported to the FDA thus far of the more than 30,000 people who have received CAR-T cell therapeutics since their approval in 2017, invariably following a relapse or when the disease has not responded to other treatment.

The FDA has previously underscored that the benefits of these immunotherapies outweigh their potential risks; the agency has also stressed the need for lifelong monitoring of patients who have received these treatments.

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