Black box warnings on CAR-T therapies

The US Food and Drug Administration (FDA) is adding black box warnings on six cell therapies about the risk of T-cell malignancies.

This follows the regulator's announcement that it had received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies.

The FDA has determined 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.