FDA probing risk of T-cell malignancy following CAR T cell immunotherapies

The FDA announced that it has 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. Reports were received from clinical trials and/or postmarketing adverse event data sources. The FDA said it 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. T-cell malignancies have occurred in patients treated with several products in the class. Currently approved products in this class include the following: Bristol Myers’ (BMY) Abecma and Breyanzi, Legend Biotech’s (LEGN) Carvykti, Novartis’ (NVS) Kymriah, Kite Pharma’s (GILD) Tecartus and Yescarta. Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action.