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Exelixis has announced that the US Food and Drug Administration (FDA) has approved CABOMETYX™ (cabozantinib) tablets for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. CABOMETYX, which was granted Fast Track and Breakthrough Therapy designations by the FDA, is the first therapy to demonstrate clinically meaningful improvement in overall survival, progression-free survival and objective response rate in a phase 3 trial for patients with advanced RCC.
The approval of CABOMETYX is based on the results of the phase 3 METEOR trial, which compared cabozantinib with everolimus, a second-line treatment for advanced RCC. Cabozantinib was associated with a 42 percent reduction in the rate of disease progression or death (PFS was 7.4 months for cabozantinib versus 3.8 months for everolimus), and significantly improved the objective response rate compared with everolimus. Cabozantinib also significantly improved overall survival in the METEOR trial, and, compared with everolimus, resulted in a 34 percent reduction in the rate of death. Median overall survival was 21.4 months for patients receiving cabozantinib versus 16.5 months for those receiving everolimus. The most common (frequency ≥25 percent) adverse reactions in cabozantinib-treated patients include diarrhoea, fatigue, nausea, decreased appetite, hand-foot syndrome, high blood pressure, vomiting, weight loss, and constipation.