Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental biologics license application (sBLA) for Breyanzi (lisocabtagene maraleucel; liso-cel) as a treatment for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have undergone at least two prior systemic therapies. The FDA has granted the application Priority Review status, with a Prescription Drug User Fee Act (PDUFA) target decision date set for December 5, 2025.
Marginal zone lymphoma patients often face multiple relapses despite initial effective treatments, underscoring the need for durable therapies. Rosanna Ricafort, vice president and Senior Global Program Lead for Hematology and Cell Therapy at Bristol Myers Squibb, emphasized the potential impact: “This FDA acceptance brings us one step closer to potentially standardizing CAR T cell therapy as a treatment option for MZL, while building on our commitment to bring this personalized therapy to as many eligible patients as possible.”
The submission draws on data from the MZL cohort of the TRANSCEND FL trial, a Phase 2, open-label, multicenter, single-arm study, which demonstrated promising results and was presented at the 2025 International Conference on Malignant Lymphoma (ICML).
Bristol Myers Squibb continues to collaborate broadly across the healthcare ecosystem to expand access to cell therapies. Recently, the FDA approved streamlined patient monitoring and removed the Risk Evaluation and Mitigation Strategy (REMS) program for Breyanzi, simplifying treatment administration while maintaining safety standards.
This development marks a significant step forward in the effort to offer new, effective therapies to patients with challenging forms of lymphoma.