The Food and Drug Administration (FDA) has approved Cabometyx (cabozantinib Exelixis) for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy.

The FDA approval was based on data from a randomized study in which patients with advanced renal cell carcinoma with prior therapy received either cabozantinib 60mg once daily (n=330) or everolimus 10mg once daily (n=328). The study’s primary endpoint was progression-free survival (PFS) among the first 375 randomized subjects. 

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The median PFS was 7.4 months in the cabozantinib arm vs. 3.8 months in the everolimus arm (HR 0.58, 95% CI: 0.45, 0.74; P<0.0001). Median overall survival was 21.4 months in the cabozantinib arm vs. 16.5 months in the everolimus arm (HR 0.66, 95% CI: 0.53, 0.83; P=0.0003). The cabozantinib group demonstrated a 17% confirmed response rate (95% CI: 13, 22) compared to a 3% rate in the everolimus group (95% CI: 2, 6).;

The most common adverse reactions included diarrhea, fatigue, nausea, decreased appetite, palmar-plantar erythrodysesthesia syndrome, hypertension, vomiting, decreased weight, and constipation.

Cabometyx, a kinase inhibitor, blocks the activity of MET, VEGFR-1, -2 and -3, AXL, RET, ROS1, TYRO3, MER, KIT, TRKB, FLT-3, and TIE-2. These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, drug resistance, and maintenance of the tumor microenvironment.

Cabometyx was granted Breakthrough Therapy designation, Fast Track, and Priority Review by the FDA. It will be available as 20mg, 40mg, and 60mg strength tablets in 30-count bottles.

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