GlaxoSmithKline announced that the US Food and Drug Administration (FDA) has approved Votrient (pazopanib) to treat patients with advanced renal cell carcinoma (RCC), a form of kidney cancer. Approximately 57,700 people in the US will be diagnosed with kidney cancer this year, and 13,000 people will die from this disease.

"RCC is the most common malignancy of the kidney and is highly resistant to chemotherapy," said Paolo Paoletti, 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. Votrient will join existing targeted therapies toprovide physicians with a new oral treatment option to their patients with advanced renal cell cancer."

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

The approval of Votrient was supported by a unanimous decision by the FDA's Oncology Drugs Advisory Committee (ODAC) that the benefit-to-risk profile for Votrient is acceptable for patients with advanced kidney cancer. The ODAC reviewed data from a phase-III clinical trial showing that Votrient reduced the risk of tumour progression or death by 54 percent compared to placebo, regardless of prior treatment.

In this phase-III trial, the overall median PFS was 9.2 months with pazopanib and 4.2 months with placebo. Treatment-naïve patients who received Votrient experienced 11.1 months of median progression-free survival (PFS) versus 2.8 months with placebo. Additionally, patients who had previously received cytokine-based treatment achieved 7.4 months of median PFS with Votrient versus 4.2 months with placebo.

The most common adverse events occurring in =20 per cent of subjects treated with Votrient included diarrhoea, hypertension, hair colour changes, nausea, anorexia, and vomiting. Grade 3/4 adverse events among these toxicities that differed by=2 per cent included abnormal liver function, hypertension, diarrhoea, asthenia, and abdominal pain. Laboratory abnormalities occurring in >10 per cent of patients and more commonly (>5%) in the pazopanib arm included increased transaminases, hyperglycaemia, leukopenia, hyperbilirubinemia, neutropenia, hypophosphatemia, thrombocytopenia, lymphocytopenia, hyponatremia, hypomagnesemia, and hypoglycaemia. Drug-related deaths were observed in 1.4 per cent of 290 patients and included hepatic failure (n=2), stroke (n=1), and perforation (n=1). Hepatic dysfunction is included as a boxed warning in the product label. Other Warnings and Precautions in the label relate to QT prolongation and torsade de pointes, haemorrhagic events, arterial thrombotic events, gastrointestinal perforation and fistula, hypertension, impaired wound healing, hypothyroidism, proteinuria, and pregnancy.