U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of RemS Programs Within Bristol Myers Squibb's Cell Therapy Labels

Published: 2025-06-27 00:05:21 ET BMY

Published on 06/27/2025 at 00:05

Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has approved label updates for both of its CAR T cell therapies, Breyanzi®? (lisocabtagene maraleucel; liso-cel) for the treatment of large B cell lymphoma (LBCL) and other lymphomas and Abecma®? (idecabtagene vicleucel; ide-cel).

Across both labels, the FDA has approved the reduction or removal of specific patient monitoring requirements for Breyanzi and Abecma. The FDA has also approved removal of the REMS requirement from each product label. 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.

Together, these label updates reflect the growing body of clinical and real-world evidence underpinning the favorable efficacy and safety profile of CAR T cell therapy. As BMS continues to bring cell therapy to more patients, the company are committed to working across the healthcare ecosystem to implement these label updates and continue to design and implement measurable programs to increase increase and equitable access to cell therapy. A pioneer in harnessing the immune system to fight cancer and an established leader in cell therapy, Bristol Myers Squibb is uniquely positioned to unlock the full potential of this technology across blood cancers and within new frontiers, including autoimmune disease.

BreyanziU.S. FDA-Approved Indications: Breyanzi is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma ("DLBCL") not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have: refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoim immunotherapy; or refractory disease to first theline chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or relapsed or refractory disease after two or more lines of systemic therapy. In clinical trials of BREYANZI, which enrolled a total of 702 patients with non-Hodgkin lymphoma (NHL), CRS occurred in 54% of patients, including Grade 3 CRS in 3.2% of patients. In clinical trials of BREyANZI, CAR T cell-associated neurologic toxicities occurred in 31% of patients, including Grade3 cases in 10% of patients.

In clinical trial of BREYANZI, CAR T cell -associated neurologic toxicities occurred In 31% of patients, including <1.2% of patients.