Bristol Myers Squibb’s Breyanzi Accepted for Priority Review by FDA for Marginal Zone Lymphoma
Tuesday, August 05, 2025
Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics licence application (sBLA) for Breyanzi® (lisocabtagene maraleucel; liso-cel) as a potential treatment for adult patients with relapsed or refractory marginal zone lymphoma (MZL).
Marginal zone lymphoma is the third most common form of non-Hodgkin lymphoma, accounting for approximately 7% of cases. It typically affects individuals around the age of 67 and is characterised by abnormal white blood cell growth in lymph nodes or organs. While initial treatment often leads to remission, relapses are common and may occur multiple times. In some cases, MZL can progress into a more aggressive form known as diffuse large B-cell lymphoma.
The application has been granted Priority Review status, with a target action date set for 5 December 2025 under the Prescription Drug User Fee Act (PDUFA).
This marks the fifth cancer type under review for Breyanzi and expands its potential use to MZL patients who have undergone at least two prior systemic treatments. The submission is supported by data from the Phase 2 TRANSCEND FL study, which assessed the safety and efficacy of Breyanzi in patients with indolent B-cell non-Hodgkin lymphoma, including MZL. Findings were presented in June 2025 at the International Conference on Malignant Lymphoma (ICML).
The Priority Review follows recent FDA approvals for more flexible patient monitoring and the removal of the Risk Evaluation and Mitigation Strategy (REMS) programme for Breyanzi, intended to improve patient access while maintaining safety standards.
Source: bms.com
