Secondary Malignancies Following CAR-T Cell Therapy | What Could We Learn from the FDA Investigation?

Response to FDA Black Box Warning


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.

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