Perspective: What the FDA’s CAR-T label change means for oncology care and patients

The FDA’s decision to remove class-wide REMS (risk evaluation and mitigation strategies) restrictions for CD19- and BCMA-directed CAR-T therapies marks a turning point—not just in regulation, but in patient access and clinical innovation¹.

For the first time, community oncology centers and health system affiliates can administer CAR-T without jumping through costly certification hoops. The revised labels halve the mandatory monitoring window—reducing post-infusion burden on patients and caregivers from 28 days to 14¹. This change is a win for operations and for patients who have faced barriers to advanced therapies due to geography, transportation, or life circumstances.

This shift also aligns with our recent research with Sarah Cannon Research Institute, which found that 98% of cytokine release syndrome (CRS) and 96% of neurotoxicity (ICANS) events occurred within the first 15 days—regardless of whether patients were in a 15-day or 30-day remote monitoring program⁴. The clinical data showed no grade 3 or 4 CRS events beyond day 15, and only a single late-occurring grade 3 ICANS event. Across both groups, 30-day survival exceeded 97%. These findings reinforce that shorter, structured monitoring windows, paired with flexible extensions based on clinical judgment, can maintain safety while reducing burden.

Why this matters for access and equity

Many rural, lower-income, and racially diverse patients have been excluded from CAR-T—not by biology, but by logistics. A treatment that requires four weeks near an academic center, with no driving and limited support, is simply not viable for many¹.

This shift removes a major structural barrier and opens the door to patients who were previously “eligible” in theory but unreachable in practice.

It also has implications for clinical trial equity: More community sites administering CAR-T increases the feasibility of decentralized trial models, improves demographic representation, and accelerates real-world evidence generation across broader populations.

Why CAR-T still demands clinical vigilance

The risk profile hasn’t changed. Recent real-world data show that CRS occurs in approximately 75% of CAR-T patients, with around 11% experiencing grade ≥3 events². ICANS occurs in approximately 27% of patients, with high-grade events in about 10%³. While most events emerge within 14 days, timely detection and structured response remain essential for patient safety.

What good safety looks like following CAR-T administration

Our clinical research with Sarah Cannon Research Institute reinforces that proximity isn’t the only determinant of safety—structure is. In a multicenter evaluation of early-phase CAR-T protocols, we observed that high reliability in CRS and ICANS management stemmed from consistent workflows, not just location.
Key findings and best practices include:

• Standardized, protocol-driven monitoring: In Sarah Cannon-affiliated programs, adherence to daily vitals and neuro assessments through day 7—paired with structured check-ins through day 14—yielded high event detection with minimal delay. This model was reproducible across both inpatient and ambulatory/home-based pathways⁴.
  
• Remote escalation tools: Sites equipped with EMR-embedded alert systems and remote vital sign feeds were able to identify fever and neuro changes within two hours of onset in >90% of flagged events⁴.
  
• Centralized triage support: A centralized nurse triage line—staffed with CAR-T trained RNs and embedded with CRS/ICANS protocols—provided 24/7 decision support to community infusion sites and caregivers, reducing unnecessary ED visits while avoiding care delays⁴.
  
• Caregiver activation and discharge readiness: Programs that implemented structured caregiver education—via teach-back modules and multilingual take-home kits—saw higher adherence to “return-to-ED” triggers and fewer late-presenting complications⁴.
  

These practices are aligned with current consensus guidelines from the ASTCT and reflect a growing body of evidence supporting decentralized monitoring models⁵.

The takeaway: Safety doesn’t require a flagship building. It requires a playbook.

Why it makes sense strategically

• For community-based leaders: This is a chance to offer cutting-edge therapies without the overhead of becoming a tertiary center—while improving retention and outcomes for your own patients.
  
• For health systems: Expanding CAR-T delivery into outlying sites boosts capacity, reduces flagship bottlenecks, and helps recapture patients who might otherwise seek care outside your network.
  
• For clinical trial leaders: Broader site access enables more representative enrollment, supports hybrid and decentralized trial designs, and accelerates real-world data capture—helping close the gap between study efficacy and population-level effectiveness.
  
• For all stakeholders: Manufacturer support is increasing, payer resistance may soften as access improves, and digital monitoring is ready to fill safety gaps—lowering your barrier to entry.
  

Key questions for clinical teams

• Are you ready to safely manage CAR-T patients in a distributed model?
  
• How will you deliver monitoring that’s reliable, scalable, and doesn’t overburden staff, patients, or caregivers?
  
• Can you use this moment to build more inclusive trial infrastructure—and deepen your footprint in the next wave of immunotherapy?
  

References

1. FDA removes barrier to CAR-T therapies access. Fierce Pharma, June 2024. Link
   
2. Sterner, R. M., et al. “Management of cytokine release syndrome and neurotoxicity associated with CAR T-cell therapy.” Clin Hematol Int. 2023;5(1):15–23. doi:10.2991/chi.k.230223.001
   
3. FDA Approves Changes to Monitoring Requirements, Removal of REMS Programs for Liso-Cel and Ide-Cel in B-Cell Malignancies. OncLive, June 2024. Link
   
4. Navneet S. Majhail et al. Outpatient Administration of Chimeric Antigen Receptor T-Cell Therapy Using Remote Patient Monitoring. JCO Oncol Pract 0, OP-25-00062. DOI:10.1200/OP-25-00062
   
5. Nastoupil, L. J., et al. “Standard-of-care axicabtagene ciloleucel for relapsed or refractory large B-cell lymphoma: results from the US Lymphoma CAR T Consortium.” J Clin Oncol. 2020;38(27):3119-3128. doi:10.1200/JCO.19.02119
   
6. Cox T, Zahradka N, Martin C, et al. Comparison of 15- vs 30-day remote patient monitoring for outpatient chimeric antigen receptor T-cell therapy (CAR-T) across a large health system. Blood. 2024;144(Suppl 1):2300. doi:10.1182/blood-2024-211566