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Savolitinib: First Approval

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posted on 31.10.2021, 22:33 by Anthony Markham

Declarations


Funding The preparation of this review was not supported by any external funding.


Authorship and Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. A. Markham is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.


Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.

Additional information about this Adis Drug Review can be found here.

Abstract

Savolitinib (Orpathys®; Hutchmed (China) Ltd., AstraZeneca) is a receptor tyrosine kinase mesenchymal epithelial transition factor (c-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/lung sarcomatoid carcinoma, savolitinib was recently granted approval in China (conditional on the results of a forthcoming phase III trial) for the treatment of metastatic NSCLC with MET exon 14 skipping alterations in patients who have progressed following prior systemic therapy or who are unable to receive chemotherapy. This article summarizes the milestones in the development of savolitinib leading to this first approval.


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