FDA OKs Exelixis’ Kidney Cancer Drug
The US Food and Drug Administration (FDA) has approved Exelixis’ Cabometyx (cabozantinib) 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 was granted fast track and breakthrough therapy designations by the FDA
In January 2016, the European Medicines Agency (EMA) validated Exelixis' marketing authorization application (MAA) for cabozantinib as a treatment for patients with advanced RCC who have received one prior therapy. The MAA has been granted accelerated assessment, making it eligible for a 150-day review, versus the standard 210 days. 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.