Tivozanib (Fotivda) has been approved by the European Commission (EC) for the treatment of patients with advanced renal cell carcinoma (RCC). Tivozanib is a potent and selective vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor (TKI) developed by AVEO Pharmaceuticals, an American pharmaceutical company.
The drug is specifically approved for the first line treatment of adult patients with advanced RCC and for adults with advanced RCC following disease progression after one prior treatment with cytokine therapy (interleukin 2 or interferon).
The approval is based on the phase III TiVO-1 trial, in which tivozanib reduced the risk of disease progression or death by over 20% versus sorafenib (Nexavar) in patients with advanced RCC who received up to 1 prior line of therapy (excluding targeted agents such as sunitinib and pazopanib).
Tivozanib is currently being appraised by the National Institute for Health and Care Excellence (NICE) for use within NHS England and Wales for advanced RCC.