赛沃替尼:批准上市。

Savolitinib: First Approval.

机构信息

Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

Drugs. 2021 Sep;81(14):1665-1670. doi: 10.1007/s40265-021-01584-0.

Abstract

Savolitinib (Orpathys; HUTCHMED, AstraZeneca) is a receptor tyrosine kinase mesenchymal epithelial transition factor (MET) inhibitor being developed for the treatment of metastatic non-small cell lung cancer (NSCLC), papillary and clear cell renal cell carcinoma (RCC), gastric cancer and colorectal cancer. Based on the results of a pivotal phase II trial in patients with NSCLC/pulmonary sarcomatoid carcinoma, savolitinib was recently granted approval in China (conditional on the results of a phase III trial) for the treatment of metastatic NSCLC with MET exon 14-skipping alterations in patients who have progressed after or who are unable to tolerate platinum-based chemotherapy. This article summarizes the milestones in the development of savolitinib leading to this first approval.

摘要

萨沃替尼(Orpathys;和黄医药、阿斯利康)是一种受体酪氨酸激酶间质上皮转化因子(MET)抑制剂,正在开发用于治疗转移性非小细胞肺癌(NSCLC)、乳头状和透明细胞肾细胞癌(RCC)、胃癌和结直肠癌。基于一项关键性 II 期临床试验的结果,该试验入组了 NSCLC/肺肉瘤样癌患者,萨沃替尼最近在中国获得批准(基于 III 期临床试验结果),用于治疗经含铂化疗后进展或不耐受的 MET 外显子 14 跳跃改变的转移性 NSCLC 患者。本文总结了导致该药首次获批的萨沃替尼研发历程中的重要事件。

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