Beyond the horizon: Strategic pathways to widespread CAR T access  

For over 70 years, BMS has redefined what the modern approach to cancer care looks like, developing nearly two dozen therapies that have successfully treated a broad range of solid tumors and hematologic malignancies. As we continue our hunt for a cure, one of the most promising approaches has been our advancements in CAR T cell therapy.

This next-generation technology harnesses a patient’s own immune system to fight their cancer — drawing blood in a process called apheresis, genetically modifying the collected T-cells at a specialized laboratory, then reinfusing this new product back into the patient — deploying an army of engineered T-cells to detect and attack cancerous ones. After CAR T infusion, patients are monitored to confirm if the treatment is working and manage potential side effects.

Due to cell therapy’s personalized nature, the process is the product — meaning that what we, as manufacturers, must provide for the patient is not just the final disease-fighting CAR T cells but also a reliable approach to ensure that treatments are delivered in an efficient and timely manner.

While real-world data has continued to demonstrate its transformative potential for certain blood cancer patients, and early studies are investigating its use in treating certain autoimmune conditions, CAR T has faced significant hurdles to widespread adoption for approved indications.

Historically, complex logistical and geographical roadblocks have prevented seamless end-to-end delivery and placed undue burden on healthcare providers (HCPs), patients and caregivers to administer and receive cell therapy. So much so that today, just two in 10 eligible patients receive treatment.

That said, the turning point is here.

In June, the U.S. Food and Drug Administration (FDA) approved sweeping updates that streamlined post‑infusion requirements, sunsetting Risk Evaluation and Mitigation Strategy (REMS) programs, reducing the timeframe patients must stay near their treatment center for monitoring and minimizing driving restrictions following treatment.

Recently, the European Medicines Agency (EMA) has followed suit, opting to streamline similar monitoring requirements for BMS cell therapies in the European Union. Together, these changes reflect a growing confidence in the management of CAR T–related adverse events and recognize what clinicians have identified in practice: that, with established guidelines and clear escalation pathways, CAR T can increasingly shift into the community setting where it would be accessible to a broader group of patients.

At BMS, it’s both our privilege and our responsibility to lead the charge toward expanding patient access to cell therapy treatments. Our 360° approach to reimagine CAR T care includes:

• A renewed focus on accelerating into the community, growing our network of qualified treatment centers to bring treatment closer to home
• Collaborative partnerships with stakeholders from across the healthcare ecosystem to challenge current practices, assumptions and barriers that continue to limit CAR T access along certain geographic, demographic or socioeconomic lines
• Ongoing efforts to reduce manufacturing complexity and improve the quality and consistency of our cell therapy products
• A deep bench of clinical programs and partnerships to explore CAR T in other disease areas, including autoimmune and solid tumors
• A comprehensive research-and-development pipeline to explore new and varied approaches to make cell therapies more streamlined and scalable, including allogeneic — or off-the-shelf — CAR T cell therapy, in vivo manufacturing and dual-targeting strategies
  

As barriers to CAR T continue to be reduced, our commitment — and the urgency to deliver on the transformational potential of this modality — only intensifies.

The future of cell therapy is bright. My hope is that continued innovations in the CAR T ecosystem will open the door to broader, more equitable access for the patients who stand to benefit.

To learn more about the downstream impact of this year’s cell therapy label updates, read more from a recent IQVIA whitepaper here. To find a treatment site for you or your patient, visit Cell Therapy 360^®.