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news.GlaxoSmithKline (GSK) has received a conditional marketing authorisation from European Commission (EC) for Votrient (pazopanib) for the first-line treatment of advanced renal cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease.
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As part of these conditions, GSK is expected to provide data from ongoing clinical studies. Earlier, FDA has approved the use of Votrient (pazopanib) as a treatment for patients with advanced RCC in October 2009.
The FDA approval of Votrient was supported by a unanimous decision by the FDA’s Oncology Drugs Advisory Committee (ODAC) that the benefit-to-risk profile for Votrient is acceptable for patients with advanced kidney cancer.
The ODAC reviewed data from a Phase III clinical trial showing that Votrient reduced the risk of tumor progression or death by 54% compared to placebo, regardless of prior treatment.
In the Phase III trial, the overall median PFS was 9.2 months with Pazopanib and 4.2 months with placebo. Treatment-naive patients who received Votrient experienced 11.1 months of median progression-free survival (PFS) versus 2.8 months with placebo.
Additionally, patients who had previously received cytokine-based treatment achieved 7.4 months of median PFS with Votrient versus 4.2 months with placebo.