Exelixis/Ipsen's Cabometyx gains approval in USA for advanced RCC
US biotech firm Exelixis (Nasdaq: EXEL) has received approval from the US Food and Drug Administration for Cabometyx (cabozantinib) tablets for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
Cabozantinib, which is currently approved in the European Union under the trade name Cometriq for the treatment of adult patients with progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC), is licensed to French drugmaker Ipsen (Euronext: IPN) for territories outside the USA, Canada and Japan (The Pharma Letter March 1).
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.
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