FDA approves Cabometyx (cabozantinib) (formerly Cometriq) to treat renal cell carcinoma.- Exelixis + Ipsen
Exelixis, Inc.announced that the FDA has approved Cabometyx (cabozantinib) (formerly Cometriq) tablets for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. RCC is the most common form of kidney cancer in adults. Cabometyx which was granted Fast Track and Breakthrough Therapy designations by the FDA, is the first therapy to demonstrate in a phase III trial for patients with advanced RCC, robust and clinically meaningful improvements in all three key efficacy parameters — overall survival, progression-free survival and objective response rate.
The approval of Cabometyx is based on results of the Phase III METEOR trial, which met its primary endpoint of improving progression-free survival. Compared with everolimus, a standard of care therapy for second-line RCC, Cabometyx was associated with a 42 percent reduction in the rate of disease progression or death. Median progression-free survival for cabozantinib was 7.4 months versus 3.8 months for everolimus (HR=0.58, 95% CI 0.45-0.74, P<0.0001). Cabometyx also significantly improved the objective response rate compared with everolimus. These data were presented at the European Cancer Congress in September 2015 and published in The New England Journal of Medicine.
Comment: Cabometyx was filed at EMA in January 2016.
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