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Drugs. 2023 Oct;83(15):1439-1445. doi: 10.1007/s40265-023-01945-x.
Talquetamab (talquetamab-tgvs; TALVEY), a humanized, bispecific G-protein coupled receptor family C group 5 member D (GPRC5D)-directed CD3 T-cell engager, is being developed by Janssen for the treatment of multiple myeloma (MM). In early August 2023, talquetamab was granted accelerated approval in the USA for the treatment of adults with relapsed or refractory MM (RRMM) and in late August 2023, talquetamab was granted conditional marketing authorisation in the EU for the treatment of adult patients with RRMM. This article summarizes the milestones in the development of talquetamab leading to this first approval for RRMM.
塔奎单抗（talquetamab-tgvs；TALVEY）是一种人源化的、双特异性 G 蛋白偶联受体家族 C 组 5 成员 D（GPRC5D）导向的 CD3 T 细胞接合器，由杨森公司开发用于治疗多发性骨髓瘤（MM）。2023 年 8 月初，塔奎单抗在美国获得加速批准，用于治疗复发或难治性多发性骨髓瘤（RRMM）成人患者；2023 年 8 月底，塔奎单抗在欧盟获得有条件上市许可，用于治疗 RRMM 成人患者。本文总结了导致这一 RRMM 首次批准的塔奎单抗开发的里程碑事件。
