This decision to remove REMS comes one year after the FDA loosened REMS requirements and removed the site mandate for CAR T educational and training materials because they deemed the product label and Medication Guides provided adequate information.² With REMS abated, hospitals and associated clinics are no longer required to maintain REMS site certification, onsite tocilizumab access, and post-treatment driving restriction time decreased from eight to two weeks.¹  

A question that comes to mind is will commitment to safety continue? The FDA has restated its commitment to safety.¹ Measures that will stay in place for CAR T include black box warnings, daily monitoring for at least one week after CAR T administration, and hospitals and centers obligation to demonstrate competency and adherence to best practices in cellular therapy to ensure patient safety. Additionally, the FDA will continue to require manufacturers to conduct post marketing observational safety studies to assess the risk of secondary malignancies and long-term safety with patient follow-up for 15 years after product administration.  

Another question that surfaces is whether REMS removal will increase CAR T utilization, allowing medication access to underserved areas and potentially drive greater outpatient administration? Likely, CAR T demand will increase gradually over time. However, sites are still required to form the infrastructure needed to create and maintain adherence to best practices for cellular therapy. Underserved areas are challenged to meet this criterion.³ Transition to outpatient CAR T administration will likely grow as providers gain experience and can identify associated toxicities early and manage them effectively outside of major academic centers and large community networks. 

With the introduction of new CAR T agents, expanded indications for existing drugs, and eventual use in non-cancer indications, CAR T utility will further expand. The end of REMS removes some administrative barriers to CAR T therapy, but questions about value remain. Can the high price of CAR T be justified when durable responses remain elusive for the majority of patients?⁴⁻⁹ Is there an opportunity to define populations most likely to benefit from therapy?   

As unwavering commitment to safety persists, questions around value will inevitably continue to emerge.