Cell therapy rules relaxed

Country

United States

The US Food and Drug Administration has relaxed some rules for chimeric antigen receptor (CAR) T cell therapies in order to minimise the tasks that healthcare providers are required to perform. From 26 June, rules known as Risk Evaluation and Mitigation Strategies (REMS) will be eliminated for six autologous CAR T cell therapies which are on the market for cancer indications. The therapies are directed against the CD19 and B-cell maturation antigens.