CAR-T Malignancy Reports Could Temper Excitement For Use Beyond Oncology

29 Nov 2023

US FDA has received a total of 19 reports of T-cell malignancy involving BCMA- or CD19-directed autologous CAR-T cell immunotherapies and is evaluating the need for regulatory action. Focus on lentiviral and retroviral vectors could extend to safety of other types of gene therapies.

Magnifying glass — The US FDA is looking closely at 19 reports of T-cell malignancies with approved CAR-T products. • Source: Shutterstock

A US Food and Drug Administration alert about reports of T-cell malignancies with CAR-T therapies could heighten safety scrutiny of lentiviral and retroviral-based gene therapies in general and temper enthusiasm for use of CAR-T products outside of oncology/hematology indications.

On 28 November, the agency announced it has received clinical trial and postmarketing reports of T-cell malignancies, including chimeric antigen...