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.