FDA Approves Cabozantinib for First-Line Treatment of Advanced Renal Cell Carcinoma

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On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted regular -approval to cabozantinib -(Cabometyx) for treatment of patients with advanced renal cell carcinoma (RCC).

The FDA previously approved cabozantinib in 2016 for treatment of patients with advanced RCC who have received prior antiangiogenic therapy. This most recent approval provides for treatment in the first-line setting.


This approval was based on data from the CABOSUN trial, a randomized, open-label phase II multicenter study in 157 patients with intermediate- and poor-risk previously untreated RCC.1 Patients received cabozantinib (n = 79) 60 mg orally daily or sunitinib (Sutent) (n = 78) 50 mg orally daily (4 weeks on treatment followed by 2 weeks off) until disease progression or unacceptable toxicity. 

Estimated median progression-free survival (as assessed by blinded independent radiology review committee) for patients taking cabozantinib was 8.6 months (95% confidence interval [CI] = 6.8–14.0) compared with 5.3 months (95% CI = 3.0–8.2) for patients taking sunitinib (hazard ratio = 0.48; 95% CI = 0.31–0.74; P = .0008).

Safety and Toxicity

The most commonly reported (≥ 25%) adverse reactions in the cabozantinib clinical program are diarrhea, fatigue, nausea, decreased appetite, hypertension, palmar-plantar erythrodysesthesia, weight loss, vomiting, dysgeusia, and stomatitis. 

The most frequent grade 3–4 adverse reactions (≥ 5%) in patients treated with cabozantinib on -CABOSUN were hypertension, diarrhea, hyponatremia, hypophosphatemia, palmar-plantar erythrodysesthesia, fatigue, alanine transaminase increase, decreased appetite, stomatitis, pain, hypotension, and syncope.

The recommended dose of cabozantinib is 60 mg orally, once daily.

Cabozantinib is also approved for the treatment of medullary thyroid cancer and is marketed under the trade name Cometriq. Cometriq and Cabometyx have different formulations and are not interchangeable.

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1. Choueiri TK, Halabi S, Sanford BL, et al: Cabozantinib versus sunitinib as initial targeted therapy for patients with metastatic renal cell carcinoma of poor or intermediate risk: The Alliance A031203 CABOSUN Trial. J Clin Oncol 35:591–597, 2017