Pazopanib Approved for Advanced Kidney Cancer

November 10, 2009

The US Food and Drug Administration approved GlaxoSmithKline’s pazopanib (Votrient), the sixth drug to be approved for kidney cancer since 2005.

The US Food and Drug Administration approved GlaxoSmithKline's pazopanib (Votrient), the sixth drug to be approved for kidney cancer since 2005.

Pazopanib is an oral medication that interferes with angiogenesis. The drug is intended for people with advanced renal cell carcinoma. In 2009, approximately 49,000 people were diagnosed with renal cell carcinoma and 11,000 people died from the disease.

"The last 5 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, MD, director, Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research.

The five other drugs approved for kidney cancer and their approval dates are: sorafenib (Nexavar, December 2005), sunitinib (Sutent, January 2006), temsirolimus (Torisel, May 2007), everolimus (Afinitor, March 2009), and bevacizumab (Avastin, July 2009).

The safety and effectiveness of pazopanib was evaluated in a 435-patient study that examined a patient's progression-free survival, which averaged 9.2 months for patients receiving pazopanib compared to 4.2 months for patients who did not receive the drug.

Adverse reactions included diarrhea, high blood pressure, hair color changes, nausea, loss of appetite, vomiting, fatigue, weakness, abdominal pain, and headache. Votrient can also cause severe and fatal liver toxicity. Health-care professionals should order blood tests to monitor liver function before and during treatment with the drug. Pazopanib should not be used during pregnancy.