Skip to main content

Tivozanib: First Global Approval

Abstract

Tivozanib (Fotivda®) is an oral, potent and highly selective vascular endothelial growth factor receptor (VEGFR) inhibitor that has been approved in the EU, Iceland and Norway for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mammalian target of rapamycin (mTOR) pathway inhibitor-naive following disease progression after one prior treatment with cytokine therapy for advanced RCC. Tivozanib is at various stages of development in other countries for advanced RCC and advanced solid tumours. This article summarizes the milestones in the development of tivozanib leading to this first global approval in Europe for the treatment of adults with advanced RCC.

This is a preview of subscription content, access via your institution.

References

  1. Bukowski RM, Figlin RA, Motzer RJ. Targeted therapy for metastatic renal cell carcinoma: introduction. In: Bukowski RM, Figlin RA, Motzer RJ, editors. Renal cell carcinoma: molecular targets and clinical applications. 3rd ed. New York: Springer Science + Business Media; 2014. p. 1–14.

    Google Scholar 

  2. Escudier B, Albiges L, Sonpavde G. Optimal management of metastatic renal cell carcinoma: current status. Drugs. 2013;73(5):427–38.

    CAS  Article  PubMed  Google Scholar 

  3. European Commission. Fotivda hard capsules: summary of product characteristics. 2017. http://ec.europa.eu. Accessed 25 Sept 2017.

  4. EUSA Pharma. Fotivda® (tivozanib) now licensed in the European Union for the first-line treatment of advanced renal cell carcinoma [media release]. 28 Aug 2017. http://www.eusapharma.com/latest-news.html.

  5. AVEO Oncology. AVEO Oncology announces FOTIVDA® (tivozanib) approved in the European Union for the treatment of advanced renal cell carcinoma [media release]. 28 Aug 2017. http://www.aveooncology.com/.

  6. Adis Insight. Drug profile: tivozanib. 2017. http://adisinsight.springer.com/. Accessed 31 Aug 2017.

  7. AVEO Oncology. AVEO 2016 annual report on form 10-K. 2017. http://www.aveooncology.com/. Accessed 25 Sep 2017.

  8. AVEO Oncology. AVEO acquires clinical stage anti-cancer compound from Kirin [media release]. 4 Jan 2007. http://www.aveooncology.com/.

  9. AVEO. Astellas and AVEO Pharmaceuticals enter into worldwide agreement to develop and commercialize tivozanib outside of Asia [media release]. 16 Feb 2011. http://www.aveooncology.com/.

  10. AVEO Oncology. AVEO Oncology announces exclusive licensing agreement with Pharmstandard for tivozanib in Russia, Ukraine and CIS [media release]. 5 Aug 2015. http://www.aveooncology.com/.

  11. AVEO Oncology. AVEO and EUSA Pharma announce exclusive licensing agreement for tivozanib in Europe [media release]. 21 Dec 2015. http://www.aveooncology.com/.

  12. AVEO Oncology. AVEO and Astellas to end worldwide collaboration license agreement for development and commercialization of tivozanib [media release]. 14 Feb 2014. http://www.aveooncology.com/.

  13. AVEO Oncology. AVEO enters into research and exclusive option agreement with Ophthotech for tivozanib (VEGF inhibitor) for the treatment of ocular diseases [media release]. 11 Nov 2014. http://www.aveooncology.com/.

  14. AVEO Oncology. SEC Filings. 2017. http://www.aveooncology.com/. Accessed 31 Aug 2017.

  15. AVEO Oncology, Astellas Oncology. AVEO and Astellas announce submission of new drug application for tivozanib for the treatment of advanced renal cell carcinoma [media release]. 28 Sep 2012. http://www.aveooncology.com/.

  16. AVEO Oncology. AVEO announces complete response letter received for tivozanib new drug application in renal cell carcinoma [media release]. 10 Jun 2013. http://www.aveooncology.com/.

  17. Jamil MO, Hathaway A, Mehta A. Tivozanib: status of development. Curr Oncol Rep. 2015;17(6):1–7.

    CAS  Article  Google Scholar 

  18. Motzer RJ, Nosov D, Eisen T, et al. Tivozanib versus sorafenib as initial targeted therapy for patients with metastatic renal cell carcinoma: results from a phase III trial. J Clin Oncol. 2013;31(30):3791–9.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  19. EUSA Pharma. Summary of Fotivda overall survival data. 2017 (data on file).

  20. Hutson T, Nosov D, Tomczak P, et al. Tivozanib vs sorafenib targeted therapy for advanced renal cell carcinoma: final results of a phase III trial (901) and efficacy results of a 2nd line tivozanib extension study (902) [abstract no. 4557 plus poster]. J Clin Oncol. 2015;33(15 Suppl).

  21. Nosov DA, Esteves B, Lipatov ON, et al. Antitumor activity and safety of tivozanib (AV-951) in a phase II randomized discontinuation trial in patients with renal cell carcinoma. J Clin Oncol. 2012;30(14):1678–85.

    CAS  Article  PubMed  Google Scholar 

  22. Eskens FA, de Jonge MJ, Bhargava P, et al. Biologic and clinical activity of tivozanib (AV-951, KRN-951), a selective inhibitor of VEGF receptor-1, -2, and -3 tyrosine kinases, in a 4-week-on, 2-week-off schedule in patients with advanced solid tumors. Clin Cancer Res. 2011;17(22):7156–63.

    CAS  Article  PubMed  Google Scholar 

  23. Rini BI, Atkins MB, Escudier BJ, et al. Tivo-3: a phase 3, randomized, controlled, multi-center, open-label study to compare tivozanib hydrochloride to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC) [abstract no. TPS4600 plus poster 395]. J Clin Oncol. 2017;35(15 Suppl).

  24. AVEO Oncology. AVEO announces dosing of first patient in the pivotal phase 3 TIVO-3 study of tivozanib in renal cell carcinoma [media release]. 26 May 2016. http://www.aveooncology.com/.

  25. AVEO Oncology. AVEO Oncology announces phase 1/2 TiNivo trial of tivozanib and Opdivo® (nivolumab) in RCC advances to phase 2 [media release]. 8 Jun 2017. http://www.aveooncology.com/.

  26. US National Institutes of Health. Clinicaltrials.gov. 2017. https://clinicaltrials.gov/. Accessed 30 Aug 2017.

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Esther S. Kim.

Ethics declarations

Funding

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. Esther Kim is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

Additional information about this Adis Drug Review can be found at http://www.medengine.com/Redeem/FD1CF060575D413E.

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

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Kim, E.S. Tivozanib: First Global Approval. Drugs 77, 1917–1923 (2017). https://doi.org/10.1007/s40265-017-0825-y

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-017-0825-y