The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of the kidney cancer agent tivozanib (Fotivda, Aveo and EUSA Pharma).
The CHMP presented a positive opinion of tivozanib (Fotivda, Aveo and EUSA Pharma), which is intended for the initial treatment of advanced renal cell carcinoma (RCC).
The full indication is for the “first line treatment of adult patients with advanced RCC and for adult patients who are VEGFR [vascular endothelial growth factor receptor] and mTOR pathway inhibitor-naive following disease progression after one prior treatment with cytokine therapy for advanced RCC.”
An oral, once-daily drug, tivozanib is not approved in the United States. It was rejected by the US Food and Drug Administration in 2013.
Tivozanib is a protein kinase inhibitor that, by blocking VEGFRs, inhibits angiogenesis, leading to inhibition of tumor growth.
According to the CHMP, tivozanib has been shown to “improve progression-free survival in patients with advanced disease.”