In the phase III trial, more than 300 patients with metastatic RCC were randomly chosen to receive Fotivda (Tivozanib) or Nexavar (Sorafenib) for a median of 19 months. While Nexavar is already approved by the Food and Drug Administration (FDA), Fotivda, an oral VEGFR inhibitor that stops the growth of new blood vessels that fuel tumors, is not.
The patients were recruited from more than 120 centers in 12 different countries in the US and Europe. Treatment began in May 2016.
- At one year, 28% of patients with Fotivda did not suffer worsening of their disease compared with 11% treated with Nexavar.
- At two years, 18% with Fotivda did not suffer worsening of their disease compared with 5% in the Nexavar group.
- At the study’s end, 70 patients (40%) in the Fotivda group and 82 patients (47%) in the Nexavar group saw their disease progress.
The most common treatment-related side effects were hypertension (20% of patients treated with Fotivda and 14% of patients treated with Nexavar).
Serious treatment-related side effects were seen in 11% of patients in the Fotivda group and 10% in the Nexavar group.
This agent has shown in clinical trials to be effective in delaying cancer growth beyond established standard protocols for patients who have returning kidney cancer. Although there are many options for patients with kidney cancer today, most are intended for first- and second-line therapy. We need a treatment like Fotivda that works for kidney cancer patients who have failed several lines of therapy.
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