In June 2025, the FDA announced a major shift in regulatory guidance: the elimination of Risk Evaluation and Mitigation Strategy (REMS) requirements for all approved autologous CART therapies targeting CD19 and BCMA. This change reflects the growing clinical experience and confidence in managing CART associated risks such as cytokine release syndrome and neurotoxicity through standard protocols.
We had the opportunity to explore the implications of this decision in a recent article featured in the SCRS inFocus newsletter. As a trusted CRO in oncology drug development, we believe this move signals a turning point in how cell therapies are accessed and delivered across diverse clinical settings.
Why the FDA’s Decision Matters
For years, REMS requirements presented operational hurdles for many clinical sites, particularly those in community or rural environments. The need for special certifications, extended post-treatment observation periods, and rapid access to emergency interventions created barriers to broader adoption.
The FDA’s June decision simplifies those requirements in three key ways:
- REMS programs are no longer required for six marketed CART products, including Yescarta, Kymriah, Breyanzi, Tecartus, Abecma, and Carvykti
- Post-treatment proximity requirements are reduced from four weeks to two weeks
- Driving restrictions have been shortened from eight weeks to two weeks
These changes open the door for a wider network of clinical sites to deliver CART therapies safely and efficiently.
What This Means for Clinical Research Sites
The removal of REMS shifts the operational landscape for trial sponsors and research sites alike. By eliminating the need for extensive certifications and infrastructure, more sites can activate quickly and begin offering trials that incorporate CART treatment arms. This helps address the longstanding gap between therapy availability and patient access.
In our SCRS article, we emphasize how this change can:
- Accelerate trial startup by reducing the regulatory burden on research sites
- Expand geographic reach to include sites in underserved or rural regions
- Improve enrollment by making trials more accessible to patients who might otherwise face logistical barriers
Thought Leadership at the Center
We are proud that SCRS selected our perspective for their inFocus newsletter, which reaches thousands of clinical site professionals, trial sponsors, and research advocates. As cell and gene therapies continue to evolve, TD2 Oncology remains committed to helping sponsors and sites navigate the regulatory and operational realities of delivering these advanced treatments.
To read the full article, visit the SCRS inFocus newsletter and look for our feature on CART access and REMS reform.
Want to explore how these updates may impact your cell therapy program?
Contact us today to discuss site strategies and protocol design options tailored to the evolving CART landscape.
