FDA removes REMS from BMS CAR-T cell therapies

The U.S. FDA has approved label updates for both of Bristol Myers Squibb’s CAR-T cell therapies, Breyanzi and Abecma, reducing patient monitoring requirements and removing the Risk Evaluation and Mitigation Strategy (REMS) programs that had been in place since initial approval.

According to BMS, the FDA has determined that the established management guidelines and extensive experience of the medical hematology/oncology community are sufficient to diagnose and manage the risks of side effects, including cytokine release syndrome and neurologic toxicities, without a REMS for the class of CD19- and BCMA-directed autologous CAR-T cell therapies. This change is likely to help further accelerate cell therapy into the community center setting. BMS says it will work closely with the more than 150 treatment centers currently approved to administer Breyanzi and Abecma to remove the REMS programs.

Additionally, across both labels, the FDA has approved the reduction or removal of specific patient monitoring requirements that posed burdens on health care delivery systems, patients and caregivers. Driving restrictions have been reduced from 8 weeks to 2 weeks post treatment and the requirement to stay within proximity of a health care facility following infusion has been reduced from 4 weeks to 2 weeks.

According to an FDA press release, the label updates apply to all currently-approved CAR-T cell therapies with REMS warnings: Gilead’s Yescarta and Tecartus, J&J’s Carvykti marketed with Legend Biotech, and Novartis’s Kymriah.

“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. 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,” said Lynelle B. Hoch, president, cell therapy organization, BMS.

Breyanzi, first approved by the FDA in February 2021, is currently approved for the treatment of large B cell lymphoma and other lymphomas; Abecma, which was developed through a partnership with 2seventy bio, was approved in March 2021 for the treatment of multiple myeloma.

*This article was updated on Friday June 27 2025 to include the FDA communication