Has CAR T Access Improved One Year After REMS Elimination?

The FDA’s elimination of the Risk Evaluation and Mitigation Strategy (REMS) for chimeric antigen receptor (CAR) T-cell therapy has eased some barriers to treatment. However, experts say geography, caregiver logistics, and disease biology still keep many eligible patients from receiving it.

Frederick L. Locke, MD, of Moffitt Cancer Center in Tampa, Florida, when speaking to Targeted Oncology in 2025, explained how the REMS was fully removed by June 2025. He described the change as recognition that the community can safely administer these treatments. In his view, the move ultimately increases access to therapy by allowing more treatment centers to offer CAR T.

Three oncologists speaking in 2026 over a year after the policy change, discussed whether access in their region has improved or not. Omar Nadeem, MD, of Dana-Farber Cancer Institute in Boston, Massachusetts, said the caregiver requirement is now 2 weeks instead of a full month, which many patients find easier to arrange. Driving restrictions have also dropped to 2 weeks. He said these changes have let clinicians discuss CAR T with many patients who previously might not have been able to pursue it, and that his center has seen increased use.

Natasha C. Edwin, MD, of Providence Portland Medical Center, in Portland, Oregon, called caregiver support and logistics the biggest barrier. She also cited disease tempo, which she said gets too little attention: patients need disease stable enough to wait about 4 weeks during manufacturing, and some are lost between cell collection and infusion. Her center now uses a GPRC5D-targeted bispecific antibody as bridging therapy to buy that time.

Edwin also pointed to geographic disparities. Only 2 centers in Oregon offer CAR T, and both are in the Portland metro area. She recognizes that the southern Oregon coast has the second-highest cancer-specific mortality in the United States after Appalachia. In her view, the gap will persist without changes to accreditation requirements and more oncologists in rural and community sites. Until then, she noted that antibody-drug conjugates are easier to administer than bispecific antibodies or CAR T, and said community physicians should be aware of this option.

Hans C. Lee, MD, of Sarah Cannon Research Institute in Nashville, Tennessee, acknowledged that access may have improved somewhat, but the change has not dramatically altered practice in his area. His practice still asks patients to stay locally for 30 days to monitor for early toxicities, which he considers part of good clinical care. Still, he said most patients who are candidates for CAR T remain unable to receive it because of these barriers.