Pyrotinib: First Global Approval
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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.
Compliance with Ethical Standards
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.
- 4.De Leon J. China approves Hengrui breast cancer drug on phase II data; 2018. https://www.biocentury.com/bc-extra/company-news/2018-08-22/china-approves-hengrui-breast-cancer-drug-phase-ii-data. Accessed 25 Sep 2018.
- 5.Lovells H. The China Food and Drug Administration pushes forward on conditional approval and compassionate use of new drugs; 2018. https://www.lexology.com/library/detail.aspx?g=73ce9342-8178-4b42-9c31-389edf0278c1. Accessed 3 Sept 2018.
- 6.State Food and Drug Administration. Pyrotinib maleate tablets: prescribing information; 2018. http://18.104.22.168. Accessed 25 Sep 2018.
- 10.Xu B, Ma F, Ouyang Q, et al. A randomized phase II trial of pyrotinib plus capecitabine versus lapatinib plus capecitabine in patients with HER2-positive metastatic breast cancer previously treated with taxanes, anthracyclines and/or trastuzumab. [abstract no. PD3-08 plus poster]. Cancer Res. 2017;78(Suppl 4).Google Scholar
- 11.Ren S, Zhou C, Gao G, et al. Preliminary results of a phase II study about the efficacy and safety of pyrotinib in patients with HER2 mutant advanced NSCLC [abstract no. MA04.03]. J Thorac Oncol. 2017;12(Suppl 1):S359.Google Scholar