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Cabozantinib (Cabometyx) was approved in 2016 for patients who have advanced renal cell carcinoma and who received prior anti-angiogenic therapy.
Cabozantinib (Cabometyx) was approved in 2016 for patients who have advanced renal cell carcinoma and received prior anti-angiogenic therapy.
The approval was based on a randomized study in which all patients enrolled had advanced renal cell carcinoma and received prior anti-angiogenic therapy. Patients were randomized to receive either cabozantinib 60 mg orally once daily (N=330) or everolimus 10 mg orally once daily (N=328).
The primary endpoint of the study was progression-free survival in the first 375 randomized subjects. Researchers found that median progression-free survival was 7.8 months in the cabozantinib cohort and 3.8 months in the everolimus cohort.
Median overall survival was 21.4 months in the cabozantinib cohort and 16.5 months in the everolimus cohort. A confirmed response rate of 17% was seen in the cabozantinib cohort and 3% in the everolimus cohort.