The marketing authorization application (MAA) submission is based on positive results from a randomized, double-blind, placebo-controlled Phase III study of pazopanib in treatment-naïve and cytokine-pre-treated patients with advanced renal cell carcinoma (RCC).
In December 2008, GlaxoSmithKline (GSK) also completed the submission of a new drug application to the FDA for pazopanib as an oral therapy for patients with advanced RCC. The filing is currently under regulatory review.
Paolo Paoletti, senior vice president of R&D oncology unit at GSK, said: “If approved, pazopanib will offer physicians and patients a new therapeutic option for advanced kidney cancer and demonstrate our ongoing commitment to the development of innovative and personalized treatments for patients with cancer.”