In a significant development, the FDA is set to impose a classwide black box warning following its investigation into secondary T-cell cancers arising from the use of existing CAR-T therapies. 

In its January 19 notification letters, the agency stressed that the potential risk applies to all currently approved CAR-T products. 

These therapies are individually approved for multiple myeloma, large B-cell lymphoma, and other blood cancers. 

The FDA specifically instructs the companies to include a paragraph in the boxed warnings indicating, “T cell malignancies may occur following treatment with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including,” followed by the product’s name. 

This directive follows the FDA’s investigation into secondary T-cell malignancies, marked as “serious,” among patients receiving BCMA- or CD19-targeted CAR-Ts. 

In November, the FDA said it received reports of patients developing T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies.

The agency said it’s weighing “the need for regulatory action” in response to clinical testing and safety monitoring reports tied to commercial use. 

The identified risk applies to all approved CAR-T therapies, although the agency noted that “the overall benefits of these products continue to outweigh their potential risks for their approved uses.

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