The FDA has approved Votrient (pazopanib) for the treatment of advanced renal cell carcinomia (RCC).

A once-daily, oral medication, pazopanib is an angiogenesis inhibitor that may help prevent the growth of new blood vessels, thereby blocking the growth of kidney cancer tumors.

The drug’s approval was supported by a unanimous decision of the FDA’s Oncology Drugs Advisory Committee, according to a press release issued by the drug’s maker, GlaxoSmithKline. The committee reviewed data from a Phase 3 clinical trial showing that the drug reduced the risk of tumor progression or death by 54% compared with placebo, regardless of prior treatment. In this trial, the overall median progression-free survival was 9.2 months with pazopanib and 4.2 months with placebo.

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Treatment-naive patients who received the medication experienced a median PFS of 11.1 months versus 2.8 months with placebo. Additionally, patients who had previously received cytokine-based treatment achieved 7.4 months of median PFS with pazopanib versus 4.2 months with placebo.

The most common adverse events occurring in 20% or more of subjects treated with pazopanib included diarrhea, hypertension, hair color changes, nausea, anorexia, and vomiting.

“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.”