Dacomitinib (Vizimpro®) is an orally administered, small-molecule irreversible inhibitor of HER1 (EGFR), HER2 and HER4 that was developed by Pfizer Inc. for the treatment of solid tumours. In September 2018, dacomitinib received its first global approval, in the USA, for use in the first-line treatment of patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. Registration applications for the use of dacomitinib as first-line treatment for patients with EGFR-mutation-positive metastatic NSCLC have also been submitted in the EU and Japan. This article summarizes the milestones in the development of dacomitinib leading to this first approval for the first-line treatment of patients with EGFR-mutated metastatic NSCLC.

中文翻译：

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达科替尼：首次全球批准。

达comitinib（Vizimpro®）是口服的小分子不可逆性HER1（EGFR），HER2和HER4抑制剂，由辉瑞公司开发，用于治疗实体瘤。2018年9月，达科替尼在美国获得了全球首个批准，用于通过FDA批准的测试检测到的具有EGFR外显子19缺失或外显子21 L858R取代突变的转移性NSCLC患者的一线治疗。欧盟和日本也已经提交了将达可替尼作为EGFR突变阳性转移性NSCLC患者一线治疗的注册申请。本文总结了达可替尼的发展过程中的里程碑，该里程碑使该药物首次获得EGFR突变转移性NSCLC患者的一线治疗。