林沃司他单抗:首次获批。
Linvoseltamab: First Approval.
作者信息
Lee Arnold
机构信息
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
出版信息
Drugs. 2025 Aug 29. doi: 10.1007/s40265-025-02207-8.
Linvoseltamab (Lynozyfic™) is a human B cell maturation antigen (BCMA)×cluster of differentiation (CD) 3 bispecific antibody that binds to both BCMA and CD3 to direct T cells against malignant B cells. Linvoseltamab is being developed by Regeneron Pharmaceuticals, Inc. for multiple indications including multiple myeloma and received its first approval on 28 Apr 2025 in the EU. This article summarises the milestones in the development of linvoseltamab leading to this first approval in the EU as monotherapy for the treatment of adult patients with relapsed/refractory multiple myeloma who have received ≥ 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
林沃妥单抗(Lynozyfic™)是一种人源化B细胞成熟抗原(BCMA)×分化簇(CD)3双特异性抗体,可同时结合BCMA和CD3,引导T细胞对抗恶性B细胞。再生元制药公司正在开发林沃妥单抗用于多种适应症,包括多发性骨髓瘤,并于2025年4月28日在欧盟获得首个批准。本文总结了林沃妥单抗在欧盟首次获批作为单药疗法治疗复发/难治性成年多发性骨髓瘤患者(这些患者此前接受过≥3种治疗,包括蛋白酶体抑制剂、免疫调节剂和抗CD38单克隆抗体,且在最后一次治疗中已出现疾病进展)过程中的各个关键节点。