KITE PHARMA, INC.

CAR T-cell Therapy Monitoring: Study Suggests Reduced REMS May Improve Accessibility

- A recent study suggests that the FDA's Risk Evaluation and Mitigation Strategy (REMS) for CAR T-cell therapy may be overly restrictive, impacting patient accessibility. - The study found that the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) is low after the first two weeks post-CAR T infusion. - Researchers propose a more flexible approach to monitoring, with a mandatory 2-week period near the treatment center, followed by individualized assessments. - Revisiting REMS mandates could reduce the physical and financial burden on patients, potentially improving access to CAR T-cell therapy, especially for underserved populations.