www.fdanews.com/articles/184961-regular-approval-granted-to-cabometyx-to-treat-carcinoma
Regular Approval Granted to Cabometyx to Treat Carcinoma
December 22, 2017
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.