The agency granted approval to Fotivda in adults with relapsed or refractory advanced renal cell carcinoma who have received two or more prior systemic therapies.
The Food and Drug Administration (FDA) on Wednesday approved Fotivda (tivozanib) for the treatment of adults with relapsed or refractory advanced renal cell carcinoma who have received two or more prior systemic therapies, according Aveo Oncology, the agent’s manufacturer.
“Today’s approval of Fotivda provides a new tool for treating patients with kidney cancer who have relapsed or become refractory to two or more prior systemic therapies,” said Dr. Brian Rini, chief of clinical trials at Vanderbilt-Ingram Cancer Center in Nashville, said in a news release. “With advances in (renal cell carcinoma) treatment, patients are living longer, increasing the need for proven, well tolerated treatment options in the relapsed or refractory setting.”
The agency based its decision on data from the phase 3 TIVO-3 trial, which was designed to evaluate Fotivda compared with Nexavar (sorafenib) in 350 patients who had received two or three prior lines of therapy.
Measuring progression-free survival (the time from treatment to disease worsening) was the main goal of the trial. Other goals included assessing overall survival and objective response rates.
Treatment with Fotivda was associated a median progression-free survival of 5.6 months compared with 3.9 months for those who were treated with Sutent. The objective response rate was 18% for the Fotivda group (175 patients) and 8% for the Sutent group (175 patients). Median overall survival, however, was higher in the Sutent group (19.2 months) than in the Fotivda group (16.4 months).
The most common side effects to occur in more than 20% of patients included, but were not limited to, fatigue, hypertension, diarrhea and decreased appetite.
“We believe in Fotivda’s potential to provide a differentiated treatment option for the growing number of individuals in the U.S. with relapsed or refractory (renal cell carcinoma), and today marks the culmination of many years of hard work and determination of many individuals to bring this therapy to patients,” Aveo’s president and CEO Michael Bailey said in the release.
The manufacturer announced that it expects to have the medication available to patients by March 31.
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