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# FDA Approves Exelixis’ Cabometyx for Kidney Cancer
- URL: https://www.fdaweb.com/fda-approves-exelixis-cabometyx-for-kidney-cancer/
- Published: 2016-04-25T12:00:00.000Z
- Updated: 2026-09-14T20:57:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135478

> FDA has approved an Exelixis NDA for Cabometyx (cabozantinib) tablets for treating patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. RCC is the most common form of kidney cancer in adults.  
>  
> Approval was based on data from the Phase 3 METEOR trial, which met its primary endpoint of improving progression-free survival. “Compared with everolimus, a standard of care therapy for second-line RCC, Cabometyx was associated with a 42% reduction in the rate of disease progression or death,” the company says. Median progression-free survival for cabozantinib was 7.4 months versus 3.8 months for everolimus, and Cabometyx also significantly improved the objective response rate compared with everolimus.  
>  
> The most common adverse reactions in Cabometyx-treated patients include diarrhea, fatigue, nausea, decreased appetite, hand-foot syndrome, high blood pressure, vomiting, weight loss, and constipation. “The rate of treatment discontinuation due to adverse reactions was low (10% in each arm) and consistent with that previously reported for everolimus,” Exelixis says.