FDA’s CAR T safety concerns may put the modality’s future at risk

There’s a new, serious safety concern for CAR T cell therapies. The possibility of a secondary cancer developing from CAR T cell treatment has gone from a theoretical risk to an actual risk, and that could change the modality’s benefit-risk calculations enough to disrupt progress as companies aim to take the technology into new patient populations.

On Tuesday, FDA issued a statement on the risk of T cell malignancy following BCMA- or CD19-directed CAR T cell therapy. The agency said it had received reports of T cell malignancies, including CAR-positive T cell lymphomas, in patients treated with the modality, and is investigating the risks and evaluating the need for regulatory action. FDA described the risk as class-wide, stating T cell malignancies have occurred after treatment with “several products.” ...