The European Commission (EC) has approved EUSA Pharma’s vascular endothelial growth factor receptor (VEGFR) inhibitor Fotivda (tivozaniv) as a first-line treatment for adults with advanced renal cell carcinoma (RCC).
The go-ahead is a significant milestone for the relatively young EUSA, and means the once-daily oral can now be launched in the EU plus Norway and Iceland.
Dr Jon Morgan, EUSA Pharma’s medical director, said: “[The] licensing of tivozanib by the EC is an important step in expanding treatment options for patients with advanced renal cell carcinoma, where, despite advancements in therapy, survival rates in advanced disease remain low.”
Kidney cancer – which is the seventh most common cancer in Europe – is accountable for an estimated 49,000 deaths each year, with RCC being the most common form of the disease.
Lee Morley, chief executive officer at EUSA Pharma, said: “Tivozanib has the potential to become an important new first-line therapy and the EU licensing is a great achievement for the EUSA team.”
The EU approval follows a recommendation from the Committee for Medicinal Products for Human Use (CHMP), based on the data from the open-label, randomised, multi-centre phase III TiVO-1 trial. This evaluated the efficacy and tolerability of the drug compared to Bayer’s currently available VEGFR-TKI treatment Nexavar (sorafenib).
The trial showed that patients treated with tivozanib experienced superior progression-free survival verses sorafenib (11.9 versus 9.1 months). Patients on tivozanib also saw an improved side effect profile, with only 14% (versus 43% with sorafenib) requiring a dose reduction due to adverse events.
EUSA Pharma, which was formed in 2005, will now work with the necessary health authorities to make tivozanib available to advanced RCC patients across Europe as quickly as possible.
Morley added: “In our short history we have made significant progress in expanding our portfolio of specialist medicines and we look forward to further strengthening our portfolio focused in the oncology field.”
The UK-based group has also recently received another EU approval for the rare cancer drug dinutuximab beta as a treatment for high-risk neuroblastoma patients over the age of one.