Ipsen is pleased to announce that its partner Exelixis, Inc. received approval from the U.S. Food and Drug Administration (FDA) for CABOMETYX™ (cabozantinib) tablets earlier today for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. On February 29, 2016, Exelixis and Ipsen jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib indications outside of the United States, Canada and Japan.
RCC is the most common form of kidney cancer in adults. The incidence of advanced RCC is estimated to be around 20,000 new patients per year in Ipsen’s territories.
CABOMETYX™, which was granted Fast Track and Breakthrough Therapy designations by the FDA, is the first therapy to demonstrate in a large, randomized phase 3 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 .
Compared with everolimus, CABOMETYX™ is associated with a 42 percent reduction in the rate of disease progression or death and 34 percent reduction in the rate of death. Median progressionfree survival for CABOMETYX™ is 7.4 months versus 3.8 months for everolimus (HR=0.58, 95% CI 0.45-0.74, P<0.0001). Median overall survival is 21.4 months for patients receiving CABOMETYX™ versus 16.5 months for those receiving everolimus (HR=0.66, 95% CI 0.53-0.83, P=0.0003).
In Europe, the Marketing Authorization Application (MAA) for cabozantinib in advanced RCC has been accepted and granted accelerated assessment. With this designation, the MAA is eligible for a 150-day review, versus the standard 210 days (excluding clock stops when information is requested by the EMA).
Exelixis press release is available here: http://bit.ly/1nuSd6O