December 4, 2009

FDA Approves Votrient for Kidney Cancer


The FDA has approved Votrient™ (pazopanib) for the treatment of advanced renal cell carcinoma (kidney cancer).

The kidneys are filled with tiny tubules that clean and filter the blood; this process removes waste and makes urine. Renal cell cancer (RCC) is a malignancy involving these tubules of the kidney. RCC is the most common type of kidney cancer; each year in the United States, more than 54,000 people are diagnosed with RCC.

Votrient is a targeted oral medication known as an angiogenesis inhibitor. The drug may help slow or prevent the growth of new blood vessels, which deprives the cancer of the oxygen and nutrients it needs to grow.

The approval of Votrient came after the results of a Phase III trial showed that the drug reduced the risk of tumor progression or death by 54% compared with placebo, regardless of prior treatment. Overall median progression-free survival was 9.2 months with Votrient compared with 4.2 months with placebo. Treatment-naïve patients experienced an even longer progression-free survival with Votrient (11.1 months compared with 2.8 months with placebo).

The most common adverse events associated with Votrient included diarrhea, hypertension, nausea, vomiting, anorexia, and changes in hair color.


FDA Approves New Treatment for Advanced Form of Kidney Cancer  [FDA News Release]. US Food and Drug Administration Web site. Available at: Accessed December 4, 2009.

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