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Drugs. 2021 Nov;81(17):2069-2074. doi: 10.1007/s40265-021-01632-9.
Mobocertinib (EXKIVITY™) is a first-in-class EGFR tyrosine kinase inhibitor being developed for the treatment of EGFR exon 20 insertion (EGFRex20ins) -positive non-small cell lung cancer (NSCLC). Based on efficacy in patients whose disease had progressed on or after platinum-based therapy in a phase I/II trial, mobocertinib was recently granted accelerated approval in the USA in this indication. The drug is also being assessed for marketing approval in various other countries and territories including the EU and China. This article summarizes the milestones in the development of mobocertinib leading to this first approval in the USA for locally advanced or metastatic EGFRex20ins-positive NSCLC that has progressed on or after platinum-based chemotherapy.
莫博赛替尼（EXKIVITY™）是一种首创的 EGFR 酪氨酸激酶抑制剂，正在开发用于治疗 EGFR 外显子 20 插入（EGFRex20ins）阳性非小细胞肺癌（NSCLC）。基于在一项 I/II 期试验中接受铂类化疗后疾病进展的患者中的疗效，莫博赛替尼最近在美国获得了该适应症的加速批准。该药还在包括欧盟和中国在内的多个其他国家和地区评估用于市场批准。本文总结了莫博赛替尼开发过程中的重要里程碑，最终在美国获得了铂类化疗后进展的局部晚期或转移性 EGFRex20ins 阳性 NSCLC 的首次批准。
