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Pyrotinib: First Global Approval

Abstract

Pyrotinib is an irreversible dual pan-ErbB receptor tyrosine kinase inhibitor developed for the treatment of HER2-positive advanced solid tumours. Based on positive results in a phase II trial, the drug recently received conditional approval in China for use in combination with capecitabine for the treatment of HER2-positive, advanced or metastatic breast cancer in patients previously treated with anthracycline or taxane chemotherapy. This article summarizes the milestones in the development of pyrotinib leading to this first global approval for the treatment of HER2-positive advanced breast cancer.

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Correspondence to Hannah A. Blair.

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

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 author on the basis of scientific completeness and accuracy. Hannah Blair is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Blair, H.A. Pyrotinib: First Global Approval. Drugs 78, 1751–1755 (2018). https://doi.org/10.1007/s40265-018-0997-0

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  • DOI: https://doi.org/10.1007/s40265-018-0997-0