TSVT - Eyes On Novartis Gilead Bristol Myers As FDA Weighs Risks Vs. Benefits Of Approved CAR T-Cell Therapies | Benzinga
Tuesday, the FDA said it received reports of patients developing 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 applies to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies. Since 2017, six CAR T-cell therapies have been approved by the FDA: