BRIEF—AVEO submits RCC option for US approval

AVEO Oncology has submitted the tyrosine kinase inhibitor tivozanib for US approval in relapsed or refractory renal cell carcinoma (RCC).

The therapy is backed by data from the TIVO-3 study, comparing tivozanib to Nexavar (sorafenib) in third and fourth line RCC patients, as well as from other trials.

AVEO will conduct a final overall survival (OS) analysis of the TIVO-3 study in the second quarter and has agreed to withdraw its submission if the hazard ratio is above 1.00.

Discovered by Kyowa Kirin, the product is approved and marketed in this indication as Fotivda in the European Union, the UK, Norway, New Zealand and Iceland.