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.