How Regulatory Changes Affect Oncology Treatments

Last week, the FDA made a quiet regulatory change with massive implications. By removing the REMS restrictions on all currently approved CD19- and BCMA-directed CAR-T therapies, the agency effectively opened the door for community-based oncology centers to deliver these treatments—without the infrastructure and proximity requirements that limited access. This isn’t just a policy tweak. It’s a rebalancing of where—and for whom—advanced cancer care can happen. At Current Health, we’ve long believed that the future of oncology is decentralized. But to make distributed CAR-T work, we need more than permission. We need systems that support safe care in the home, with proven monitoring and escalation pathways, built for the real world. Our research with customers like Sarah Cannon Cancer Network and Mount Sinai Health System has shown it’s possible. With the right digital tools, 24/7 clinical oversight, triage protocols, and caregiver engagement, community sites can match the vigilance & success of flagship programs—without burning out staff or sacrificing safety. This is a moment for clinical leaders to take stock. To ask: - Can we safely expand access without expanding risk? - Are we ready to support decentralized delivery models—at scale? - How can we use this shift to improve clinical trial inclusion, not just throughput? This change could double the number of eligible patients in some regions. The responsibility to monitor them, care for them, and include them in research has just expanded as well. Let’s be ready.

FDA Eliminates REMS for CAR-T Therapies: Why This Is an Important Step Forward The FDA's decision last week to eliminate Risk Evaluation and Mitigation Strategies (REMS) for BCMA- and CD19-directed CAR-T therapies represents meaningful progress in the ongoing effort to expand patient access. What this regulatory change accomplishes: 1. Removes hospital certification barriers that previously limited treatment sites 2. Streamlines administrative processes for healthcare systems 3. Reflects "growing body of real-world evidence and regulatory confidence in the safety profile" of these therapies The Access Challenge Continues While this is a positive step, significant barriers remain. Currently, only about 2 in 10 eligible patients receive cell therapy, and geographic access continues to be a major challenge for patients in rural and underserved communities. Opportunities for Point-of-Care Expansion This regulatory streamlining creates new possibilities for: 🏥 Expanding treatment capabilities beyond major academic centers 🤝 Building collaborative networks with community oncology practices 📍 Reducing travel burdens through regional treatment options It's one step in a longer journey toward equitable access. The infrastructure, training, and logistics challenges remain significant, but the FDA's willingness to work with industry to reduce unnecessary barriers is encouraging. For patients in rural areas who currently travel hundreds of miles for treatment, every step toward more accessible care matters. #CARTtherapy #HealthEquity #CancerCare #FDA #RuralHealthcare #OncologyAccess https://lnkd.in/eDaG_Hd9

The FDA’s decision to remove #REMS requirements for all approved BCMA- and CD19-directed CAR-T therapies marks a critical inflection point for the #cellandgenetherapy sector. Historically the parameters required to deliver #CART, including certified treatment centers, extended monitoring, and restrictive driving guidelines, created access barriers. Last month's regulatory update brings meaningful change with the removal of some of those hurdles, especially for patients outside of major academic hospitals. This decision reflects growing confidence in the hematology-oncology community’s ability to manage the risks of these therapies, and it opens the door for broader administration in community settings. From a policy standpoint, this is a signal that #FDA is willing to evolve alongside the science, recognizing the safety data, clinical maturity, and operational readiness that now characterize commercial CAR-T programs. It also demonstrates the agency’s interest in expanding reach without compromising safety, a theme that will be increasingly important as we move beyond oncology into autoimmune disease and other complex indications. As the industry continues to improve logistics, scale manufacturing, and strengthen delivery, this milestone is a reminder that improving access to these groundbreaking therapies is the ultimate goal.