Savolitinib: First Approval

Overview

Journal Drugs

Specialty Pharmacology

Date 2021 Aug 29

PMID 34455538

Citations 50

Authors

Anthony Markham

Affiliations

Soon will be listed here.

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.

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References

Ding Q, Ou M, Zhu H, Wang Y, Jia J, Sai Y . Effect of food on the single-dose pharmacokinetics and tolerability of savolitinib in Chinese healthy volunteers. Fundam Clin Pharmacol. 2021; 36(1):210-217. DOI: 10.1111/fcp.12697. View

Lu S, Fang J, Li X, Cao L, Zhou J, Guo Q . Once-daily savolitinib in Chinese patients with pulmonary sarcomatoid carcinomas and other non-small-cell lung cancers harbouring MET exon 14 skipping alterations: a multicentre, single-arm, open-label, phase 2 study. Lancet Respir Med. 2021; 9(10):1154-1164. DOI: 10.1016/S2213-2600(21)00084-9. View

Lee J, Kim S, Kim K, Lee H, Kozarewa I, Mortimer P . Tumor Genomic Profiling Guides Patients with Metastatic Gastric Cancer to Targeted Treatment: The VIKTORY Umbrella Trial. Cancer Discov. 2019; 9(10):1388-1405. DOI: 10.1158/2159-8290.CD-19-0442. View