CAR-T in Community Settings: Expanding Access with Proven Safety

Community oncology is on the cusp of a new chapter. In June 2025, the FDA removed the Risk Evaluation and Mitigation Strategies (REMS) programs for all currently approved CD19- and BCMA-directed autologous CAR-T therapies—Yescarta, Kymriah, Tecartus, Breyanzi, Abecma, and Carvykti. Regulators concluded that a REMS is no longer necessary to ensure the benefits of these therapies outweigh the risks, reflecting growing confidence in providers’ ability to manage CAR-T safety profiles.  

 

With more than 200 CAR-T therapy trials currently underway and promising progress in addressing solid malignancies, the market is well positioned to grow dramatically in the next few years.  

Alongside REMS removal, key label changes shortened the post-infusion monitoring period from four weeks to two and reduced driving restrictions from eight weeks to two. This action shows community oncology leaders that regulators trust local teams to deliver CAR-T in community settings safely—provided the right clinical governance and safety measures are in place. 

 

What’s changed and what hasn’t. 

 

What changed 

• REMS requirements eliminated: All approved CD19- and BCMA-directed autologous CAR-Ts no longer require formal center certification or REMS-specific processes such as on-site tocilizumab stocking. 

• Monitoring requirements eased: Updated labels now call for only two weeks of close patient proximity and driving restrictions. 

What hasn’t changed 

• Boxed warnings remain: CAR-T therapies still carry boxed warnings for cytokine release syndrome (CRS) and neurologic toxicities. 

• Long-term oversight required: Safety follow-up and adverse event reporting continue to be essential. 

• Internal safeguards critical: Clinical teams must still detect, document, and manage complications like CRS, ICANS and infections quickly, with internal processes now the backbone of safe delivery. 

Evidence behind the policy shift. 

The FDA’s decision was driven by mounting real-world evidence showing that most serious CAR-T side effects occur in the first two weeks after infusion, rarely later. 

 

An important analysis was led by our team at the Sarah Cannon Transplant and Cellular Therapy Network in collaboration with Current Health, and published in Blood in 2024. The study compared 15-day versus 30-day remote patient monitoring programs across four SCTCTN sites, analyzing outcomes in more than 200 patients who received FDA-approved CAR-T therapies (Blood 2024;144(Suppl 1):2300). 

 

The findings: 

• 98% of CRS events occurred within the first 15 days 

• 96% of ICANS cases also developed during that same window 

• No grade 3/4 CRS events were seen beyond day 15 

• Only a single grade 3 ICANS case appeared after day 15 

• Thirty-day overall survival was 97–98% across both monitoring cohorts 

For clinicians, this confirms that the most intensive monitoring is best concentrated in the first two weeks—exactly the change the FDA has now codified into labeling. It also validates that structured outpatient programs, supported by remote monitoring and clear escalation protocols, can safely manage CAR-T patients closer to home. 

 

Outpatient and hybrid CAR-T models. 

The OUTREACH trial—the largest prospective outpatient CAR-T study—showed that care outside of the hospital isn’t just possible, it can be highly effective. In this study of patients with relapsed or refractory LBCL treated with lisocabtagene maraleucel (liso-cel), about 70% were infused as outpatients, and one in four never needed to be hospitalized at all. 

 

For those who did require admission, the experience was still far lighter: patients infused as outpatients had a median hospital stay of just six days, compared with 15 days for those admitted upfront. Critically, outcomes were not compromised. Response rates were strong, with 80% of patients achieving an objective response and over half achieving a complete response. Safety was reassuring as well—no cases of severe (grade ≥3) CRS were reported, and rates of neurotoxicity and infection were consistent with expectations. 

 

The takeaway: when the right monitoring and escalation protocols are in place, outpatient and hybrid CAR-T models can deliver excellent outcomes while dramatically reducing disruption for patients and caregivers. 

Closing the CAR-T access gap. 

 

Despite the progress, access to CAR-T remains limited today. Surveys of U.S. community oncologists reveal that only about 6% administer CAR-T directly in their own practices, and nearly 40% refer fewer than half of their eligible patients. That means a large proportion of people who could benefit from these therapies never get the chance. 

 

The reasons are multifactorial including logistical barriers, lack of local infrastructure, patient reluctance or inability to travel, and the burden of prolonged monitoring requirements under the old REMS programs. However, the impact is clear with thousands of eligible patients currently missing out on a potentially life-saving option. 

 

By reducing monitoring from four weeks to two and removing certification hurdles, the FDA has lowered some of the biggest barriers to community adoption. For patients with transportation challenges, caregiver limitations, or geographic constraints, these changes can be the difference between being offered CAR-T and being left behind. 

 

For community oncology programs, the opportunity is significant. Even starting with a limited scope, such as lower-risk patients or hybrid inpatient/outpatient models, can expand access, keep more patients closer to home, and begin to close a gap that has left too many without treatment. 

 

How to operationalize CAR-T safely. 

Community programs ready to deliver CAR-T locally should focus on six priorities, as identified from our work with Sarah Cannon Transplant and Cellular Therapy Network: 

 

1. Patient selection: Start with lower-risk patients, using clear criteria to triage inpatient vs. outpatient infusion. 

2. Front-loaded monitoring: Concentrate follow-up in the first 14 days when nearly all serious toxicities occur. 

3. Escalation protocols: Define explicit thresholds for hospital transfer or ICU escalation, with warm lines to referral centers. 

4. Rapid access to interventions: Maintain immediate availability of tocilizumab, steroids, and other rescue therapies. 

5. Documentation and oversight: Capture toxicity grading and interventions consistently in the EHR to support quality and billing. 

6. Caregiver enablement: Even with shorter proximity rules, caregiver education and support remain essential. 

 

The bottom line. 

The FDA’s removal of REMS requirements reflects confidence that CAR-T can be delivered more broadly, but it also raises the bar for local accountability. Multiple studies demonstrate that most serious risks occur in the first two weeks, validating shorter monitoring and supporting broader adoption. 

 

For community oncology, the opportunity is clear: with structured safeguards, CAR-T in community settings can expand access, reduce patient burden, and maintain safety standards once thought possible only in academic centers. 

 

How Current Health helps. 

At Current Health, we provide the clinical operating system that supports safe CAR-T in community settings: 

• Proven clinical monitoring and escalation workflows tailored to the first 14 days post-infusion 

• 24/7 nurse triage and proactive engagement 

• EHR integration for streamlined visibility, documentation, billing, and reporting 

• Patient and caregiver enablement tools for early detection and rapid action for complications 

 

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