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Drugs. 2023 Jul;83(10):935-941. doi: 10.1007/s40265-023-01894-5.
Glofitamab (Columvi) is a CD20 × CD3 T-cell-engaging bispecific monoclonal antibody being developed by Roche for the treatment of B-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma (DLBCL). Glofitamab received its first approval (with conditions) on 25 March 2023, in Canada, for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, DLBCL arising from follicular lymphoma, or primary mediastinal B-cell lymphoma, who have received two or more lines of systemic therapy and are ineligible to receive or cannot receive CAR T-cell therapy or have previously received CAR T-cell therapy. Glofitamab is also under regulatory review for relapsed or refractory DLBCL in the EU and USA and in April 2023 received a positive opinion recommending the granting of a conditional marketing authorization in the EU. Clinical development of glofitamab, as a monotherapy and in combination with other agents for the treatment of non-Hodgkin lymphomas, is continuing worldwide. This article summarizes the milestones in the development of glofitamab leading to this first approval for relapsed or refractory DLBCL.
格罗菲妥单抗（Columvi）是罗氏公司开发的一种用于治疗 B 细胞非霍奇金淋巴瘤的 CD20×CD3 T 细胞结合双特异性单克隆抗体，包括弥漫性大 B 细胞淋巴瘤（DLBCL）。格罗菲妥单抗于 2023 年 3 月 25 日在加拿大首次获得批准（有条件），用于治疗复发或难治性弥漫性大 B 细胞淋巴瘤（DLBCL）、滤泡性淋巴瘤起源的弥漫性大 B 细胞淋巴瘤或原发性纵隔 B 细胞淋巴瘤的成年患者，这些患者已接受过两线或以上的系统治疗，不符合接受嵌合抗原受体 T 细胞（CAR T）疗法的条件或不能接受 CAR T 疗法，或先前已接受过 CAR T 疗法。格罗菲妥单抗在欧盟和美国也正在接受复发或难治性 DLBCL 的监管审查，2023 年 4 月在欧盟获得了积极意见，建议有条件批准上市。格罗菲妥单抗作为单药以及与其他药物联合用于治疗非霍奇金淋巴瘤的临床开发正在全球范围内继续进行。本文总结了格罗菲妥单抗开发过程中的重要里程碑，最终使其在复发或难治性 DLBCL 中获得批准。
