FDA launching investigation into CAR-T therapies after identifying several cases of post-treatment blood cancer

The FDA announced it is launching an investigation into the safety of CAR-T therapies following several reports of patients who developed blood cancers following treatment with BCMA- or CD19-directed autologous CAR-T cell immunotherapies. Reports were received from clinical trials and/or post-marketing adverse event data sources, including the FDA’s self-reporting adverse event system, FAERS, and included accounts of serious outcomes, including hospitalization and death.

The agency said that the risk of T-cell malignancies “is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies.” This includes Bristol Myers Squibb’s Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel), Johnson & Johnson and Legend Biotech’s Carvykti (ciltacabtagene autoleucel), Novartis’s Kymriah (tisagenlecleucel), and Gilead and Kite’s Yescarta’s Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel).