Urology FDA approvals of 2016
FDA grants approval to treatment for advanced RCC
Exelixis has announced that the FDA approved cabozantinib (Cabometyx), which targets multiple tyrosine kinases, for the treatment of patients with advanced renal cell carcinoma who have received prior angiogenic therapy. In a phase III trial of patients with advanced RCC, the therapy demonstrated clinically meaningful improvements in all three key efficacy parameters—overall survival, progression-free survival, and objective response rate. In comparison with treatments using everolimus, cabozantinib demonstrated a 42% reduction in the rate of disease progression or death. Median progression-free survival for cabozantinib was 7.4 months compared to 3.8 months for everolimus, and median overall survival was 21.4 months for cabozantinib-treated patients versus 16.5 months for those treated with everolimus. The most common side effects associated with cabozantinib include diarrhea, fatigue, nausea, decreased appetite, hand-foot syndrome, high blood pressure, vomiting, weight loss, and constipation.
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