GSK Obtains Unanimous FDA Panel Approval Recommendation For Votrient

GlaxoSmithKline (GSK) has received FDA’s Oncologic Drugs Advisory Committee (ODAC) recommendation in support of the approval of Votrient (pazopanib).

Reportedly, the panel voted that the benefit-to-risk profile is acceptable for patients with advanced renal cell carcinoma (RCC). Pazopanib is an investigational, oral treatment for patients with advanced RCC.

The company said that the advisory committee made its decision based on phase III pivotal trial data that were presented at the American Society of Clinical Oncology 2009 annual meeting.

Rafael Amado, vice president of Oncology R&D Unit at GlaxoSmithKline, said: “Kidney cancer is a very serious disease therefore the committee’s recommendation in support of pazopanib is an important step towards bringing a new, oral treatment option to advanced renal cell cancer patients. We look forward to working with the FDA towards the approval of pazopanib.”