Abstract:
On November 28, 2023, the U.S. Food and Drug Administration (FDA) announced that it had launched an investigation into the risk of T-cell malignancies following autologous Chimeric Antigen Receptor (CAR-)T cell immunotherapies. While the Agency stated that T cell malignancies observed in clinical trials as well as post-marketing adverse event monitoring programs were the trigger for this investigation, their announcement did not provide further information. This has led to a wave of confusion among the Cell and Gene Therapy Community. We address key areas and questions concerning the FDA’s recent announcement in the interest of our scientific and research community.