AVEO and Astellas file NDA for tivozanib in kidney cancer

USA-based AVEO Oncology (Nasdaq: AVEO) and Japanese drug major Astellas Pharma (TSE:4503) have submitted a New Drug Application to the US Food and Drug Administration seeking approval for tivozanib in patients with advanced renal cell carcinoma (RCC). Tivozanib is designed to target the vascular endothelial growth factor (VEGF) pathway, a clinically validated target in RCC and other solid tumors.

Last year, the companies entered into a worldwide agreement outside of Asia to develop and commercialize tivozanib, under the terms of which AVEO received an initial cash payment of $125 million, and is also eligible to receive nearly $1.3 billion in potential milestones, as well as more than $780 million in commercial milestones (The Pharma Letter February 17, 2011).

If approved, tivozanib would be the first drug on the market developed by AVEO.The therapy is currently being evaluated in additional tumor types, with results expected shortly. It will compete with currently approved drugs such as Bayer and Onyx; Nexavar (sorafenib) and Pfizer’s Sutent (sunitinib).