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)..
百時美施貴寶公司宣佈，美國食品藥品監督管理局 (FDA) 已接受 Breyanzi®（lisocabtagene maraleucel；liso-cel）的補充生物製品許可申請 (sBLA)，作爲治療成人復發或難治性邊緣區淋巴瘤 (MZL) 的潛在療法。
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.
邊緣區淋巴瘤是非霍奇金淋巴瘤的第三種常見形式，約佔病例的7%。它通常影響大約67歲左右的個體，特徵是淋巴結或器官中白細胞異常增長。雖然初始治療常常導致緩解，但復發很常見，且可能多次發生。
In some cases, MZL can progress into a more aggressive form known as diffuse large B-cell lymphoma..
在某些情況下，MZL可能進展爲一種更具侵襲性的形式，稱爲瀰漫性大B細胞淋巴瘤。
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).
該申請已獲得優先審查狀態，根據《處方藥使用者費用法案》（PDUFA），目標行動日期定爲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.
這標誌着Breyanzi正在審查的第五種癌症類型，並將其潛在用途擴展到至少接受過兩次先前全身治療的MZL患者。此次提交得到了2期TRANSCEND FL研究的數據支持，該研究評估了Breyanzi在惰性B細胞非霍奇金淋巴瘤（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，在國際惡性淋巴瘤會議（ICML）上公佈了研究結果。
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.
優先審查是在近期FDA批准更靈活的患者監測以及取消Breyanzi的風險評估與緩解策略（REMS）計劃之後進行的，旨在改善患者獲取途徑的同時保持安全標準。
Source: bms.com
來源：bms.com