FDA Relaxes CAR-T Therapy Requirements, Boosting Access and Commercialization

The FDA has officially eliminated Risk Evaluation and Mitigation Strategies (REMS) for all approved BCMA- and CD19-directed autologous CAR T-cell immunotherapies. This decision reflects the FDA’s confidence that the benefits of these therapies now outweigh their risks without the need for a REMS, significantly reducing burdens on the healthcare system.

Why the Change?

Previously, CAR T-cell therapies (including Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, Yescarta) required REMS due to risks like cytokine release syndrome (CRS) and neurological toxicities. This meant restricted access, requiring certified hospitals and immediate tocilizumab access.

New Patient Monitoring Guidelines:

While REMS are gone, product labeling updates streamline patient care:

• Monitor patients for at least two weeks (daily for at least one week).
• Remain near a healthcare facility for at least two weeks.
• Avoid driving for two weeks.

This move is expected to improve access, especially for patients in rural areas. The FDA notes the medical community’s growing expertise in managing CAR T-cell toxicities and stable adverse event reporting. Key risk information will continue to be highlighted in product labeling (including boxed warnings).

Continued Safety Oversight: Routine adverse event reporting remains in effect, and manufacturers must still conduct 15-year post-marketing safety studies to monitor for secondary malignancies and long-term safety.