FDA approves therapy for advanced renal cell carcinoma

October 29, 2009

The FDA has approved GlaxoSmithKline?s pazopanib (Votrient) to treat patients with advanced renal cell carcinoma.

The FDA has approved GlaxoSmithKline’s pazopanib (Votrient) to treat patients with advanced renal cell carcinoma.

Pazopanib, a once-daily oral medication, is an angiogenesis inhibitor that may help prevent the growth of new blood vessels, thereby blocking the growth of kidney cancer tumors that need blood vessels to survive.

A phase III clinical trial of the drug showed that pazopanib 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 pazopanib and 4.2 months with placebo. Treatment-naïve patients who received pazopanib experienced 11.1 months of median progression-free survival versus 2.8 months with placebo.

The most common adverse events occurring in ≥20% of subjects treated with the drug included diarrhea, hypertension, hair color changes, nausea, anorexia, and vomiting. Grade 3/4 adverse events among these toxicities that differed by ≥2% included abnormal liver function, hypertension, diarrhea, asthenia, and abdominal pain.