Abstract
Jiangsu Chia-Tai Tianqing Pharmaceutical and Advenchen Laboratories are co-developing anlotinib (Focus V®) for the treatment of advanced cancer. Anlotinib is an oral small molecule inhibitor of multiple receptor tyrosine kinases, with a broad spectrum of inhibitory effects on tumour angiogenesis and growth. Anlotinib is approved in China for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have undergone progression or recurrence after ≥ 2 lines of systemic chemotherapy. Anlotinib is also undergoing phase II and/or III clinical development for various sarcomas and carcinomas in China, USA and Italy. This article summarizes the milestones in the development of anlotinib leading to this first approval for NSCLC.
Similar content being viewed by others
Change history
06 August 2018
Following a once-daily on days 1–14 of each 21-day cycle regimen, plasma concentrations of anlotinib reached maximum on day 14 and decreased subsequently with the 7-day rest period until the start of the next treatment cycle [2].
References
Regad T, Targeting RTK. Signaling pathways in cancer. Cancers. 2015;7(3):1758–84.
Sun Y, Niu W, Du F, et al. Safety, pharmacokinetics, and antitumor properties of anlotinib, an oral multi-target tyrosine kinase inhibitor, in patients with advanced refractory solid tumors. J Hematol Oncol. 2016;9(1):105.
Syrigos KN, Saif MW, Karapanagiotou EM, et al. The need for third-line treatment in non-small cell lung cancer: an overview of new options. Anticancer Res. 2011;31(2):649–59.
Chia Tai Tianqing Pharmaceutical. Anlotinib hydrochloride capsules. 2018. https://www.cttq.com Accessed 29 May 2018.
Advenchen Laboratories. 2018. http://advenchen.com. Accessed 30 May 2018.
Xie C, Wan X, Quan H, et al. Preclinical characterization of anlotinib, a highly potent and selective vascular endothelial growth factor receptor-2 inhibitor. Cancer Sci. 2018;109(4):1207–19.
Lin B, Song X, Yang D, et al. Anlotinib inhibits angiogenesis via suppressing the activation of VEGFR2, PDGFRbeta and FGFR1. Gene. 2018;654:77–86.
Taurin S, Yang CH, Reyes M, et al. Endometrial cancers harboring mutated fibroblast growth factor receptor 2 protein are successfully treated with a new small tyrosine kinase inhibitor in an orthotopic mouse model. Int J Gynecol Cancer. 2018;28(1):152–60.
Han B, Li K, Wang Q, et al. Efficacy and safety of third-line treatment with anlotinib in patients with refractory advanced non-small-cell lung cancer (ALTER-0303): a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2017;18(Suppl 1):S3.
Han B, Li K, Wang Q, et al. Efficiency of anlotinib as 3rd line treatment in patients with different EGFR gene status, an exploratory subgroup analysis of ALTER0303 trial [abstract no. P3.03-006]. J Thorac Oncol. 2017;12(11 Suppl 2):S2275.
Han B, Zhao Y, Li K, et al. Blood samples NGS for baseline molecular signature of anotinib treated advanced NSCLC patients in ALTER0303 trial [abstract no. P3.03-017]. J Thorac Oncol. 2017;12(11 Suppl 2):S2279.
Li K, Wang J, Han B, et al. Impact factor analysis for efficacy and prognosis of anlotinib in NSCLC as third-line treatment: data from trial alter 0303 [abstract no. P3.01-087]. J Thorac Oncol. 2017;12(11 Suppl 2):S2236.
Li K, Wang J, Wang X, et al. Level of activated circulating endothelial cells to predict progression-free survival of anlotinib treatment in patients with NSCLC: analysis on ALTER-0303 study [abstract no. e20530]. J Clin Oncol. 2017;35(15 Suppl):e20530.
Han B, Li K, Zhao Y, et al. Anlotinib as a third-line therapy in patients with refractory advanced non-small-cell lung cancer: a multicentre, randomised phase II trial (ALTER0302). Br J Cancer. 2018;118(5):654–61.
Zhou AP, Bai Y, Song Y, et al. Anlotinib in metastatic renal cell carcinoma (mRCC) with a previous anti-VEGFR TKI: preliminary results from a multicenter, phase II trial [abstract no. e16082]. J Clin Oncol. 2016;34(15 Suppl):e16082.
Chi Y, Sun Y, Cai J, et al. Phase II study of anlotinib for treatment of advanced soft tissues sarcomas [abstract no. 11005]. J Clin Oncol. 2016;34(Suppl 15):11005.
Zhou AP, Ma J, Bai Y, et al. Anlotinib versus sunitinib as first line treatment for metastatic renal cell carcinoma (mRCC): preliminary results from a randomized phase II clinical trial [abstract no. 4565]. J Clin Oncol. 2016;34(15 Supplement):4565.
Sun Y, Chi Y, Tang P, et al. Phase II study of anlotinib for treatment of advanced medullary thyroid carcinoma [abstract no. 6015]. J Clin Oncol. 2016;34(15 Suppl):6015.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Funding
The preparation of this review was not supported by any external funding.
Conflicts 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. Yahiya Y. Syed is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.
Additional information
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.
Rights and permissions
About this article
Cite this article
Syed, Y.Y. Anlotinib: First Global Approval. Drugs 78, 1057–1062 (2018). https://doi.org/10.1007/s40265-018-0939-x
Published:
Issue Date:
DOI: https://doi.org/10.1007/s40265-018-0939-x