PBR Staff Writer Published 13 February 2018
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Eusa Pharma’s Fotivda (tivozanib) as a first line treatment for adult patients with advanced renal cell carcinoma (aRCC).
Discovered by Kyowa Hakko Kirin, Tivozanib is an oral, once-daily and vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).
In the European Union, Norway and Iceland, tivozanib is indicated as a first line treatment for adult patients with aRCC.
It is also indicated for adult patients who are vascular endothelial growth factor receptor (VEGFR) and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for aRCC.
Eusa Pharma holds rights for tivozanib in Europe, North and South Africa, Latin America and Australasia. The positive recommendation will fetch a $2m milestone payment to Aveo Oncology from Eusa Pharma.
As per terms of the deal established in December 2015, Aveo is eligible to receive up to $386m from Eusa Pharma as future research and development funding and milestone payments.
The deal includes the payment of a tiered royalty ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the deal’s territories.
At present, tivozanib is being assessed in the phase 3 TIVO-3 trial, which is a randomized, controlled, multi-center and open-label study comparing tivozanib to sorafenib in subjects with refractory advanced RCC.
Aveo president and CEO Michael Bailey said: “The recommendation from NICE marks the first European Union reimbursement approval for Fotivda, helping ensure broadening patient access to Fotivda in key European markets following its launch in Germany in the fall of 2017.
“We continue to execute on our strategic plans, and we have had a very productive 2018 thus far, with the recent presentation of positive preliminary data from our tivozanib and nivolumab combination TiNivo study in RCC and an investigator sponsored study of tivozanib in liver cancer.”