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)..

百时美施贵宝公司宣布，美国食品药品监督管理局 (FDA) 已接受 Breyanzi®（lisocabtagene maraleucel；liso-cel）的补充生物制品许可申请 (sBLA)，作为治疗成人复发或难治性边缘区淋巴瘤 (MZL) 的潜在疗法。

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.

边缘区淋巴瘤是非霍奇金淋巴瘤的第三种常见形式，约占病例的7%。它通常影响大约67岁左右的个体，特征是淋巴结或器官中白细胞异常增长。虽然初始治疗常常导致缓解，但复发很常见，且可能多次发生。

In some cases, MZL can progress into a more aggressive form known as diffuse large B-cell lymphoma..

在某些情况下，MZL可能进展为一种更具侵袭性的形式，称为弥漫性大B细胞淋巴瘤。

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).

该申请已获得优先审查状态，根据《处方药使用者费用法案》（PDUFA），目标行动日期定为2025年12月5日。

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.

这标志着Breyanzi正在审查的第五种癌症类型，并将其潜在用途扩展到至少接受过两次先前全身治疗的MZL患者。此次提交得到了2期TRANSCEND FL研究的数据支持，该研究评估了Breyanzi在惰性B细胞非霍奇金淋巴瘤（包括MZL）患者中的安全性和有效性。

Findings were presented in June 2025 at the International Conference on Malignant Lymphoma (ICML)..

2025年6月，在国际恶性淋巴瘤会议（ICML）上公布了研究结果。

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.

优先审查是在近期FDA批准更灵活的患者监测以及取消Breyanzi的风险评估与缓解策略（REMS）计划之后进行的，旨在改善患者获取途径的同时保持安全标准。