FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Regular Approval Granted to Cabometyx to Treat Carcinoma

Dec. 26, 2017
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The FDA granted regular approval to Cabometyx (cabozantinib), a drug developed by Exelixis for the treatment of patients with advanced renal cell carcinoma.

The drug’s approval was based on data from a randomized, open-label trial. The phase 2 multicenter study involved 157 patients and produced results estimating the median progression-free survival for trial participants taking Cabometyx to be 8.2 months — an improvement of 2.6 months over the other drug in the study, sunitinib.

The FDA previously approved Cabometryx for treatment of advanced RCC in 2016 among patients who received prior anti-angiogenic therapy.

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