NVS - Gilead's Tecartus Dropped From FDA List Of CAR-T Therapy With Updated Label Warning Of Risks Of Secondary Cancer' | Benzinga
Tuesday, the FDA announced to impose a classwide black box warning following its investigation into secondary T-cell cancers arising from the use of existing CAR-T therapies.
“We consider this information to be “new safety information” as defined in section 505-1(b)(3) of the FDCA. Furthermore, we consider the serious risk of T cell malignancy to be applicable to all BCMA- and CD19-directed genetically modified autologous T cell immunotherapies.”
In its January 19 notification letters, the agency stressed that the potential risk applies to all currently approved CAR-T products.
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