GSK's Votrient Receives FDA approval

Published: 19-Oct-2009

To treat patients with advanced renal cell carcinoma

The FDA has approved GlaxoSmithKline's (GSK) Votrient (pazopanib) to treat patients with advanced renal cell carcinoma (RCC).

Votrient, a once-daily, oral medication, is an angiogenesis inhibitor which may help prevent the growth of new blood vessels, thereby blocking the growth of kidney cancer tumors that need blood vessels to survive, said the company.

Reportedly, the 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 company said that ODAC has 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.

Paolo Paoletti, senior vice president at GSK Oncology R&D Unit, said: "Votrient will join existing targeted therapies to provide physicians with a new oral treatment option to their patients with advanced renal cell cancer."

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