FDA Okays new treatment for advanced kidney cancer

Monday Oct 19, 2009 (foodconsumer.org) -- The U.S. Food and Drug Administration announced today that it has approved Votrioent or pazopanib, made by GlaxoSmithKline for treatment of advanced kidney cancer.

Votrient, the sixth drug approved for kidney cancer since 2005, is an oral medication that affects the cancer cells by interfering with angiogenesis, the growth of new blood vessels that are needed for solid tumors to grow and survive.

The drug is intended for people with renal cell carcinoma, a type of kidney cancer in which cancerous cells are found in the lining of very small tubes in the kidney.

An estimated 49,000 people will be diagnosed with this type of kidney cancer and 11,000 people will die 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.

The other five drugs approved for kidney cancer are Sorafenib (approved in December 2005), Sunitinib (January 2006), Temsirolimus (May 2007), Everolimus (March 2009), and Bevacizumab (July 2009), the FDA says on its website.

The safety and effectiveness of Votrient was tested in a trial of 435 patients. Patients who received the drug had 9.2 months of progress-free survival compared to 4.2 months for those who did not use the drug.

Adverse effects included diarrhea, high blood pressure, hair color changes, nausea, loss of appetite, vomiting, fatigue, weakness, abdominal pain and headache.

Votrient can cause severe and fatal liver toxicity. Health care professionals are advised to monitor liver function before and during the treatment with the drug.

The drug can also harm fetuses and thus can't be used during pregnancy. In addition, it is associated with heart rhythm irregularities and patients on the medication should be monitored with periodic electrocardiograms.

By David Liu davidl at foodconsumer dot org