The US Food and Drug Administration (FDA) is investigating reports of a “serious risk” of T-cell malignancies linked to treatment with chimeric antigen receptor (CAR) T-cell therapies. The investigation includes currently approved B-cell maturation antigen (BCMA) and CD19-directed autologous CAR T-cell immunotherapies.
The investigation was prompted by 20 reports of serious adverse events, including hospitalizations and deaths associated with these therapies since the approval of the first CAR-T therapy in 2017. Fifteen of the reports came from FDA’s Adverse Event Reporting System (FAERS) and five were reported from clinical trials. An FDA spokesperson said the reports “suggest that T cell malignancy is an identified risk for approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies.”…
