FDA Approves Cabometyx for Advanced Renal Cell Carcinoma

In April, the U.S. Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis) to treat advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy. The approval was based on a randomized study in which patients with advanced RCC who had received prior anti-angiogenic therapy received either cabozantinib 60 mg orally once daily or everolimus 10 mg orally once daily with a primary endpoint of progression-free survival among the first 375 randomized subjects. Median progression-free survival was 7.4 months and 3.8 months in the cabozantinib and everolimus arms, respectively. Median overall survival in the intent-to-treat population was 21.4 months and 16.5 months in the cabozantinib and everolimus arms, respectively. And, confirmed response rate was 17 percent in the cabozantinib arm and 3 percent in the everolimus arm. The most common adverse reactions included diarrhea, fatigue, nausea, decreased appetite, palmar-plantar erythrodysesthesia syndrome, hypertension, vomiting, weight loss and constipation. Sixty percent of patients treated with cabozantinib had at least one dose reduction while in the study. Serious adverse events, which included abdominal pain, pleural effusion, diarrhea and nausea, were reported in 40 percent of patients.