Savolitinib: First Approval
Savolitinib: First Approval
复制标题
DOI：
10.1007/s40265-021-01584-0
复制
发表时间：
2021-08-29
期刊：
影响因子：
11.5
通讯作者：
Markham, Anthony
中科院分区：
文献类型：
--
作者：
Markham, Anthony
Savolitinib（Orpathys（R）; HUTCHMED，AstraZeneca）是一种受体酪氨酸激酶间充质上皮转化因子（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。基于一项在NSCLC/肺肉瘤样癌患者中开展的关键性II期试验的结果，savolitinib最近在中国获批（以III期试验的结果为条件），用于治疗铂类化疗后进展或无法耐受铂类化疗的转移性NSCLC伴MET外显子14跳跃改变的患者。本文总结了savolitinib开发过程中导致首次批准的里程碑。
Savolitinib (Orpathys(R); 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.