Bristol Myers Squibb (BMS) received U.S. Food and Drug Administration (FDA) approval for label updates for its CAR T cell therapies, Breyanzi (lisocabtagene maraleucel; liso-cel) to treat large B cell lymphoma (LBCL) and other lymphomas, and Abecma (idecabtagene vicleucel; ide-cel) to treat multiple myeloma. 

These label updates reduce certain patient monitoring requirements and remove the Risk Evaluation and Mitigation Strategy (REMS) programs that had been in place since each product was initially approved.

The FDA has approved the reduction or removal of specific patient monitoring requirements for Breyanzi and Abecma. These prolonged requirements posed burdens on healthcare delivery systems, and for certain patients and their care partners, particularly those who live far from certified cell therapy treatment centers.

With the updates, driving restrictions are reduced from 8 weeks to 2 weeks post-treatments, and the requirement to stay within proximity of a healthcare facility following infusion is reduced from 4 weeks to 2 weeks.

A REMS program is often required to help mitigate known or potential risks associated with new drugs or therapies. The FDA has since 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 (CRS) and neurologic toxicities (NTs), without a REMS for the class of CD19- and BCMA-directed autologous CAR T cell therapies. 

Following this announcement, BMS will work closely with the more than 150 treatment centers currently approved to administer Breyanzi and Abecma to remove the REMS programs. 

BMS is also focused on rapidly expanding the geographic footprint of cell therapy, with a renewed effort to add community cancer centers nationwide to administer Breyanzi and Abecma closer to patients, helping further reduce travel time and duration of stay away from home, family, and work.