The FDA has approved Votrient (pazopanib tablets, from GlaxoSmithKline), an angiogenesis inhibitor, for the treatment of advanced renal cell carcinoma (RCC). This approval was based on results from a Phase 3 clinical trial which showed that Votrient reduced the risk of tumor progression or death by 54% compared to placebo, regardless of prior treatment. Overall median progression-free survival (PFS) was 9.2 months with Votrient and 4.2 months with placebo. Treatment-naive patients who received Votrient experienced 11.1 months of median 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 compared to 4.2 months with placebo.
Votrient is expected to be available in mid-November 2009.
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