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Drugs. 2016 Feb;76(2):275-81. doi: 10.1007/s40265-015-0536-1.
Daratumumab (Darzalex™) is a first-in-class, humanized IgG1κ monoclonal antibody that targets the CD38 epitope and was developed by Janssen Biotech and Genmab. Intravenous daratumumab was recently approved via an accelerated approval programme in the USA for patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. The drug is in preregistration for this indication in the EU and Canada. In a phase II trial in patients with previously treated (as described above) relapsed or refractory multiple myeloma, monotherapy with daratumumab 16 mg/kg achieved an overall response rate of approximately 30 %. This article summarizes the milestones in the development of daratumumab leading to this first approval for multiple myeloma.
达雷妥尤单抗（Darzalex™）是一种首创的、人源化 IgG1κ 单克隆抗体，靶向 CD38 表位，由杨森生物技术公司和 Genmab 开发。静脉注射用达雷妥尤单抗最近通过美国的加速批准程序获得批准，用于至少接受过三线治疗（包括蛋白酶体抑制剂[PI]和免疫调节剂）的多发性骨髓瘤患者，或对 PI 和免疫调节剂均有双重耐药性的患者。该药正在欧盟和加拿大为此适应症进行预注册。在一项既往治疗（如上所述）的复发或难治性多发性骨髓瘤患者的 II 期试验中，达雷妥尤单抗 16mg/kg 的单药治疗总体缓解率约为 30%。本文总结了达雷妥尤单抗开发过程中的重要里程碑，最终使其首次获批用于多发性骨髓瘤。
