FDA Approves Streamlined Monitoring Requirements and REMS Program Removal for Bristol Myers Squibb’s CAR T Cell Therapies Breyanzi and Abecma, Marking Milestone Toward Expanding Access to Cancer Treatment
In a significant regulatory development, Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has approved critical label updates for its two chimeric antigen receptor (CAR) T cell therapies—Breyanzi® (lisocabtagene maraleucel; liso-cel) and Abecma® (idecabtagene vicleucel; ide-cel). The updates pertain to treatments for large B-cell lymphoma (LBCL) and multiple myeloma, respectively. This new regulatory action significantly reduces certain patient monitoring obligations and eliminates the Risk Evaluation and Mitigation Strategy (REMS) programs that were required upon the original approvals of these advanced cell therapies.
The FDA’s approval underscores a pivotal step in simplifying the delivery of CAR T cell therapies, which are recognized as revolutionary yet complex cancer treatments. While these therapies offer potentially curative outcomes, real-world access remains limited. According to Bristol Myers Squibb (BMS), only about 20% of eligible patients currently receive CAR T therapy, largely due to logistical, geographic, and operational hurdles that make treatment difficult to access.
Regulatory Updates Designed to Ease the Burden
The FDA’s decision includes substantial revisions to post-treatment care protocols that were originally implemented to ensure safety. These changes apply to both Breyanzi and Abecma, and are based on accumulating clinical and real-world data showing the safety and efficacy of these treatments, particularly in the early post-infusion period where most side effects emerge.
Key label modifications include:
- Reduction of driving restrictions: Patients are now advised to refrain from driving for two weeks post-infusion, down from the previously mandated eight weeks.
- Shortened proximity requirement: Patients are now only required to stay near a certified treatment center for two weeks post-treatment instead of four weeks.
These changes are expected to reduce the logistical and financial burden on patients and caregivers, particularly for those residing far from specialized cell therapy centers.
Removal of REMS Requirements
One of the most impactful changes is the complete removal of the REMS programs for both Breyanzi and Abecma. REMS programs are typically instituted by the FDA to ensure that the benefits of certain medications outweigh their risks. In the case of CAR T therapies, the REMS programs were originally introduced to monitor and mitigate the risk of serious adverse effects like cytokine release syndrome (CRS) and neurologic toxicities (NTs).
However, after years of clinical use and the development of robust treatment management guidelines, the FDA has concluded that the current medical community, particularly hematologists and oncologists, are now sufficiently trained and experienced to manage these risks without the additional regulatory oversight of a REMS.
The FDA’s updated position reflects the agency’s increasing confidence in the field’s maturity and infrastructure surrounding CAR T cell therapy and is aligned with a class-wide change affecting all CD19- and BCMA-directed autologous CAR T therapies.
A Step Toward Greater Access and Equity
Bristol Myers Squibb has long advocated for reducing access barriers to its cell therapy portfolio. With the FDA’s recent label updates, the company plans to work closely with over 150 existing treatment centers authorized to administer Breyanzi and Abecma, ensuring a smooth transition from the REMS framework and updated patient care protocols.
Moreover, BMS is doubling down on its efforts to broaden the geographic availability of these therapies by enabling more community-based cancer centers to offer CAR T treatments. Traditionally, CAR T therapy has been confined to large academic or research hospitals due to its complexity. However, with growing provider expertise and updated regulatory guidance, decentralizing the administration of cell therapy may finally be within reach.
This strategy not only supports reduced travel times and financial burden on patients and families but also opens the door for more equitable access across underserved and rural communities.
Patient Advocacy Groups Welcome the Decision
The decision to streamline post-treatment monitoring and remove REMS oversight has been positively received by patient advocacy organizations.
“Living with blood cancer is challenging, but patients and their loved ones still need to maintain jobs, take care of families, and plan for the future,” said Sally Werner, CEO of Cancer Support Community. “Today’s announcement reduces some of the most onerous requirements that may have previously discouraged patients, particularly those who live far from a treatment center, from seeking the potentially transformational effects of cell therapy. We applaud any and all efforts to continue to break down barriers, reduce time burden on patients and caregivers, and increase uptake of this life-saving therapy.”
Clinical Experience Driving Policy Change
To date, more than 30,000 patients have been treated with CAR T cell therapies in the U.S., and a wealth of both clinical trial and real-world data supports the safety profile of these therapies when properly administered and monitored. Notably, research presented by BMS at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting confirmed that the overwhelming majority of serious side effects like CRS and NTs occur within the first two weeks of treatment, making extended monitoring beyond that period largely unnecessary.
This growing body of evidence has given regulators the confidence to reduce restrictions, a decision that aligns with the evolving standard of care in oncology and cell therapy.
Industry Implications and Forward-Looking Outlook
The FDA’s decision to approve streamlined monitoring requirements and remove REMS for Breyanzi and Abecma is likely to have ripple effects across the CAR T therapy landscape. By reducing the administrative and logistical complexity of offering CAR T treatments, this action could accelerate adoption across the industry and motivate other biopharmaceutical companies to reassess how they design and support the commercial rollouts of their own cell therapy products.
“CAR T cell therapy is a transformational, potentially life-saving option for patients living with blood cancers, and we are working to challenge current practices, assumptions, and barriers that limit access,” said Lynelle B. Hoch, President of Bristol Myers Squibb’s Cell Therapy Organization. “Today’s FDA-approved label updates reinforce BMS’ continued efforts to collaborate across the healthcare ecosystem, with the ultimate goal of reaching more patients and democratizing access to cell therapy.”
As BMS pushes forward with its strategy to decentralize CAR T delivery, expand center availability, and partner with community practices, the company continues to position itself as a leader in making complex oncology treatments more accessible. If successful, these changes could signal a turning point not only in the uptake of cell therapies but also in the broader mission of ensuring equity in cancer care.
The FDA’s approval of these label modifications for Breyanzi and Abecma is more than a regulatory update—it is a strategic shift toward making personalized cancer therapies more accessible, less burdensome, and better integrated into real-world care settings. For patients battling aggressive blood cancers and for the health systems that support them, this evolution in treatment protocols could mean quicker access, fewer hospital stays, and ultimately, improved outcomes.
