On December 19, 2017,
The Food and Drug Administration granted regular approval to cabozantinib (Cabometyx, Exelixis, Inc.) for treatment of patients with advanced renal cell carcinoma (RCC).
The FDA previously approved Cabometyx in 2016 for treatment of patients with advanced RCC who have received prior anti-angiogenic therapy. Today’s approval provides for treatment in the first-line setting.
This approval was based on data from CABOSUN (NCT01835158), a randomized, open-label phase 2 multicenter study in 157 patients with intermediate and poor-risk previously untreated RCC. Patients received Cabometyx (n=79) 60 mg orally daily or sunitinib (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 Cabometyx was 8.6 months (95% 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=0.0008).
The recommended dose of Cabometyx is 60 mg orally, once daily.