TIVOZANIB APPROVED FOR RENAL CANCER BY EMA

On August 28, AVEO Oncology announced that the European Commission (EC) has approved tivozanib (Fotivda) for the treatment of adult patients with advanced renal cell carcinoma in the European Union plus Norway and Iceland.

Tivozanib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma and for adult patients 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, potent, and highly-selective vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor. 

The U.S. Food and Drug Administration rejected a marketing application for tivozanib in 2013, citing concerns about the design of the TIVO-1 trial in which the drug was evaluated (see below) and requiring additional clinical studies.

Bernard Escudier, MD, Medical Oncologist and member of the Genitourinary Tumor Board of Gustave Roussy, France, commented “This is excellent news for patients with metastatic renal cell carcinoma. Outcomes in this disease have greatly improved with the introduction of targeted therapies, meaning that patients are living for longer. However, we are still in need of effective and well-tolerated new treatments in metastatic renal cell carcinoma and thus, tivozanib is a welcomed addition.”

TIVO-1

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. EUSA Pharma has indicated that it intends to now work with the necessary health authorities to make tivozanib available to patients with advanced renal cell carcinoma across Europe as quickly as possible.