Bristol Myers Squibb Gains U.S. FDA Approval to Remove REMS Programs and Ease Monitoring Rules for Breyanzi and Abecma Cell Therapies

Why did the U.S. FDA approve reduced monitoring and removal of REMS for Bristol Myers Squibb’s CAR T therapies in 2025?

The U.S. Food and Drug Administration has approved substantial label updates for Bristol Myers Squibb’s two autologous CAR T cell therapies—Breyanzi (lisocabtagene maraleucel) and Abecma (idecabtagene vicleucel). These updates, disclosed in June 2025, include eliminating the Risk Evaluation and Mitigation Strategy (REMS) programs and easing post-infusion monitoring protocols. These changes apply to Breyanzi, indicated for multiple types of large B cell lymphoma (LBCL), and Abecma, indicated for relapsed or refractory multiple myeloma.

The regulatory greenlight comes as real-world data and clinical outcomes increasingly confirm the manageable safety profile of CD19- and BCMA-directed CAR T therapies, particularly for the adverse events like cytokine release syndrome (CRS) and neurotoxicity (NT). With these label revisions, Bristol Myers Squibb (NYSE: BMY) aims to lower access barriers that have restricted patient uptake despite cell therapy’s transformative promise in blood cancers.

How do the updated FDA label requirements impact patient logistics and provider access for CAR T treatments?

Historically, logistical constraints surrounding CAR T therapy—such as prolonged monitoring and geographic restrictions due to REMS-mandated proximity to specialized centers—have significantly limited adoption. Only around 20% of eligible patients receive CAR T treatment in the United States, according to institutional estimates.

Under the newly approved guidelines:

Patients will now be required to stay near a treatment facility for only two weeks post-infusion, down from four.

Driving restrictions post-treatment have been shortened to two weeks instead of the prior eight-week precaution.

More significantly, the FDA eliminated the REMS program from the Breyanzi and Abecma labels. The REMS program had required treatment administration at certified centers with specialized safety protocols. Its removal opens the door to broader use in community-based cancer centers, reducing the burden on tertiary hospitals and bringing therapies closer to patients.

Bristol Myers Squibb plans to work with its network of over 150 certified sites and is proactively expanding to community oncology clinics, potentially reaching patients previously sidelined due to distance and time barriers.

What expert and institutional sentiment underpins the FDA’s decision and future uptake expectations?

Analysts and institutional investors broadly interpret the FDA’s move as a validation of the safety and scalability of Bristol Myers Squibb’s CAR T assets. The agency’s decision is underpinned by a growing body of real-world and trial data, including findings presented at the 2025 ASCO Annual Meeting, where most serious side effects were shown to occur within two weeks post-infusion—the new monitoring threshold.

Institutional sentiment suggests that removing REMS designation is a signal of regulatory maturity for the therapy class. The removal may also stimulate payer confidence, streamline hospital workflows, and support faster time-to-treatment for patients, all of which are conducive to higher market penetration in the medium term.

Sally Werner, CEO of the Cancer Support Community, emphasized that these updates reduce caregiver burden and increase therapy access for patients who previously opted out due to extended travel or prolonged treatment center stays.

What are the safety outcomes that supported the REMS removal for Breyanzi and Abecma in the U.S.?

The decision to remove REMS and reduce monitoring requirements is backed by comprehensive safety data. More than 30,000 patients globally have received autologous CAR T therapies. For both Breyanzi and Abecma, serious events such as CRS and neurotoxicity typically manifested within the first two weeks, suggesting that extended monitoring may offer limited additional safety value.

For Breyanzi, CRS occurred in 54% of patients, but Grade ≥3 events were limited to 3.2%, and nearly all cases resolved within five days. Neurologic toxicity occurred in 31% of patients, with serious events in 10%, most resolving within a week.

For Abecma, CRS affected 89% of patients, but severe cases were confined to 7%. Neurotoxicity was observed in 40% of patients, but only 4.6% experienced Grade 3 or higher events. The median onset was within 1–2 days, and most cases resolved within a week.

The U.S. FDA concluded that healthcare providers now have sufficient experience and clinical guidelines to independently manage these risks without REMS oversight, particularly in settings with hematology/oncology specialization.

How does this regulatory shift affect Bristol Myers Squibb’s position in the CAR T therapy market?

Bristol Myers Squibb is currently the only biopharmaceutical company with two FDA-approved CAR T therapies targeting distinct antigens (CD19 and BCMA) across multiple blood cancer indications. This dual-asset positioning provides strategic leverage in the growing market for autologous cell therapies.

Removing regulatory friction may enable Bristol Myers Squibb to accelerate commercial uptake, particularly in second-line LBCL and triple-class refractory multiple myeloma. The label update also aligns with Bristol Myers Squibb’s long-term strategic vision to treat hundreds of thousands of patients with cell therapy as manufacturing, delivery, and reimbursement ecosystems mature.

Internally, the American oncology innovator is investing in expanding manufacturing capacity and exploring next-generation CAR T constructs for autoimmune diseases and solid tumors. These initiatives are supported by extensive translational data and a robust internal pipeline.

The changes also give Bristol Myers Squibb a first-mover advantage in community center adoption, potentially outpacing CAR T rivals constrained by ongoing REMS requirements or narrower clinical data sets.

What is the longer-term outlook for patient access, institutional adoption, and commercial expansion of BMS CAR T programs?

The FDA’s decision marks a pivotal inflection point in the evolution of CAR T from specialty tertiary center treatment to a more mainstream oncology modality. Bristol Myers Squibb has confirmed its intent to expand its certified site network and work collaboratively with the healthcare ecosystem to operationalize these new label terms.

Analysts expect a material increase in new patient initiations, particularly in suburban and rural geographies that were previously underserved. Institutional payers may now view the therapy with greater logistical feasibility, unlocking further formulary approvals.

On the financial front, reduced administrative and travel burden is likely to improve patient adherence, shorten treatment cycles, and optimize hospital throughput, especially for centers treating multiple cancer types. Investors are monitoring this trend as a potential earnings inflection driver in the 2025–2027 period.

Importantly, the updates also remove a psychological barrier for patients—especially those balancing work, family, and illness—by enabling shorter proximity mandates, thereby reducing career disruption and personal expense.