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Drugs. 2020 Nov;80(16):1731-1737. doi: 10.1007/s40265-020-01405-w.
Tafasitamab (tafasitamab-cxix; MONJUVI) is an Fc-modified (i.e. two amino acid substitutions within the Fc region, resulting in increased Fcγ receptor affinity), humanized, anti-CD19 monoclonal antibody. Developed by MorphoSys AG, under a license from Xencor, it received accelerated approval (in July 2020) for use in combination with lenalidomide as a treatment for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplantation (ASCT). It is the first therapy to be approved as a second-line treatment for this patient population in the USA. The recommended dose of tafasitamab is 12 mg per kg of bodyweight, administered via an intravenous infusion. A regulatory assessment for tafasitamab plus lenalidomide for the treatment of adults with relapsed or refractory DLBCL is currently underway in the EU. Tafasitamab is also being clinically investigated as a therapeutic option in various other B-cell malignancies, including follicular lymphoma and other indolent non-Hodgkin's lymphoma. This article summarizes the milestones in the development of tafasitamab leading to this first approval for its use in combination with lenalidomide in adults with relapsed or refractory DLBCL.
他塞替单抗（tafasitamab-cxix；MONJUVI）是一种 Fc 修饰（即在 Fc 区域内发生两个氨基酸取代，导致 Fcγ 受体亲和力增加）的人源化抗 CD19 单克隆抗体。由 MorphoSys AG 开发，Xencor 授权，它获得了加速批准（2020 年 7 月），与来那度胺联合用于治疗复发或难治性弥漫性大 B 细胞淋巴瘤（DLBCL）的成人患者，这些患者未特指其他类型，包括源自低级别淋巴瘤的 DLBCL，且不符合自体干细胞移植（ASCT）条件。它是美国首个被批准用于该患者人群二线治疗的疗法。他塞替单抗的推荐剂量为 12mg/kg 体重，通过静脉输注给药。在欧盟，正在对他塞替单抗与来那度胺联合用于治疗复发或难治性 DLBCL 的成人患者进行监管评估。他塞替单抗也正在各种其他 B 细胞恶性肿瘤中作为一种治疗选择进行临床研究，包括滤泡性淋巴瘤和其他惰性非霍奇金淋巴瘤。本文总结了导致他塞替单抗首次获批与来那度胺联合用于治疗复发或难治性 DLBCL 成人患者的发展里程碑。
