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European Commission Approves Tivozanib in Treatment of Advanced Renal Cell Carcinoma

On August 28, the European Commission approved tivozanib (Fotivda) for the treatment of adults with advanced renal cell carcinoma in the European Union plus Norway and Iceland, according to an announcement by AVEO Oncology.

Tivozanib is indicated for the first-line treatment of adults with advanced renal cell carcinoma and adults who are vascular endothelial growth factor receptor (VEGFR) and mTOR pathway inhibitor–naive following disease progression after one prior treatment with cytokine therapy for advanced renal cell carcinoma. Tivozanib is an oral, once-daily, VEGFR tyrosine kinase inhibitor.

The approval is based primarily on data from the global, open-label, randomized, multicenter phase III TIVO-1 trial. In this study, the efficacy and tolerability of tivozanib were compared with sorafenib in 517 patients with advanced renal cell carcinoma. Tivozanib was associated with a longer progression-free survival than sorafenib (11.9 vs. 9.1 months in the overall population [P=.042] and 12.7 vs 9.1 months in treatment-naive patients [P=.037]). As for toxicity, 14% of patients treated with tivozanib required a dose reduction due to adverse events, compared with 43% of those treated with sorafenib.

In 2013, the U.S. Food and Drug Administration rejected a marketing application for tivozanib, citing concerns about the design of the TIVO-1 trial and requiring additional clinical studies.