特泊替尼：首次获批。

Tepotinib: First Approval.

机构信息

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

出版信息

Drugs. 2020 Jun;80(8):829-833. doi: 10.1007/s40265-020-01317-9.

Abstract

Tepotinib (Tepmetko™, Merck) is a MET tyrosine kinase inhibitor being developed for the treatment of solid tumours. In quarter three of 2019 tepotinib was granted breakthrough therapy status by the US FDA and orphan drug designation by the Japanese Ministry of Health, Labour and Welfare for the treatment of non-small cell lung cancer harbouring MET alterations, and in March 2020 was approved for use in Japan in this indication. This article summarizes the milestones in the development of tepotinib leading to this first approval.

摘要

特泊替尼（Tepmetko™，默克公司）是一种 MET 酪氨酸激酶抑制剂，目前正在开发用于治疗实体瘤。2019 年第三季度，特泊替尼获得了美国食品药品监督管理局（FDA）的突破性治疗药物认定和日本厚生劳动省（MHLW）的孤儿药认定，用于治疗携带 MET 改变的非小细胞肺癌，并且在 2020 年 3 月，该药在日本获得批准，用于该适应证。本文总结了特泊替尼研发过程中的重要里程碑事件，直至该药获得首次批准。