The FDA announced it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for six currently approved B-cell maturation antigen (BCMA)- and CD19-directed autologous chimeric antigen receptor (CAR) T-cell immunotherapies. The products are gene therapies currently approved to treat blood cancers, such as multiple myeloma and certain types of leukemia and lymphoma.
“The FDA has taken the bold step to remove the Risk Evaluation and Mitigation Strategy requirement from giving
JULY 8, 2025