European Commission approves Fotivda (tivozanib) for the treatment of patients with advanced renal cell carcinoma.-Aveo Oncology + EUSA Pharma.

Aveo Oncology has announced that the European Commission (EC) has approved Fotivda (tivozanib) for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland. Tivozanib is indicated for the first line treatment of adult patients with advanced RCC and for adult patients who are vascular endothelial growth factor receptor (VEGFR) and mTOR pathway inhibitor-na�ve following disease progression after one prior treatment with cytokine therapy for advanced RCC.

The approval from the EC was primarily based on data from a global, open-label, randomized, multicenter phase III trial�TIVO-1�which evaluated the efficacy and tolerability of tivozanib compared to a currently available comparator VEGFR tyrosine kinase inhibitor treatment (sorafenib [Nexavar]) in 517 patients with advanced renal cell carcinoma. Patients treated with tivozanib experienced superior progression-free survival (11.9 vs 9.1 months in the overall population [hazard ratio [HR] = 0.797; 95% confidence interval [CI] = 0.639�0.993; P = .042] and 12.7 vs 9.1 months in treatment-naive patients [HR = 0.756; 95% CI = 0.580�0.985; P = .037]) vs sorafenib. There was also an improved side-effect profile with tivozanib, with only 14% (vs 43% with sorafenib) requiring a dose reduction due to adverse events. In addition, fewer people on tivozanib experienced burdensome side effects, such as diarrhea (23% vs 33%) and hand-foot syndrome (14% vs 54%).

EUSA Pharma, a specialty pharmaceutical company with a focus on oncology and oncology supportive care, is the European licensee for tivozanib. Tivozanib is an oral, once-daily, potent and highly-selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI).