FDA Approves GlaxoSmithKline's Votrient

Votrient is a cancer medication that interferes with the growth of cancer cells and slows their spread in the body. Votrient is used to treat advanced renal cell carcinoma (kidney cancer).

GlaxoSmithKline announced that the U.S. Food and Drug Administration (FDA) has approved VOTRIENT (pazopanib) to treat patients with advanced renal cell carcinoma, a form of kidney cancer. Approximately 57,700 people in the U.S. will be diagnosed with kidney cancer this year, and 13,000 people will die from this disease.

"RCC is the most common malignancy of the kidney and is highly resistant to chemotherapy," said Paolo Paoletti, MD, Senior Vice President, GlaxoSmithKline Oncology R&D Unit. "While treatment has improved in the past few years with the introduction of targeted therapies, advanced RCC remains a challenging disease. VOTRIENT will join existing targeted therapies to provide physicians with a new oral treatment option to their patients with advanced renal cell cancer."

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.

The U.S. Food and Drug Administration today approved Votrient (pazopanib), the sixth drug to be approved for kidney cancer since 2005.

Votrient is an oral medication that interferes with angiogenesis, the growth of new blood vessels needed for solid tumors to grow and survive.

Votrient is intended for people with advanced renal cell carcinoma, a type of kidney cancer in which the cancerous cells are found in the lining of very small tubes (tubules) in the kidney. In 2009, approximately 49,000 people were diagnosed with renal cell carcinoma and 11,000 people died from the disease.

“The last five years have seen dramatic improvements in treatment options for patients with kidney cancer. Before 2005, the options available offered only limited effectiveness,” said Richard Pazdur, M.D., director, Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.

Pazopanib is used to treat kidney cancer. It belongs to a class of drugs known as tyrosine kinase inhibitors. Pazopanib works by decreasing the blood supply to the cancer tumor to slow tumor growth.