FDA Approval for GlaxoSmithKline

Yesterday, GlaxoSmithKline (GSK - Analyst Report) received some good news with the US Food and Drug Administration’s (FDA) approval of Votrient (pazopanib) for the treatment of patients with advanced renal cell carcinoma (RCC), a form of kidney cancer. However, the FDA approval does not come as a surprise to us as earlier this month the FDA’s Oncologic Drugs Advisory Committee (ODAC) had voted unanimously in favor of the drug. 

The favorable recommendation was based on encouraging results from a phase III trial of Votrient, in which the drug reduced the risk of tumor progression or death by 54% compared to placebo, regardless of prior treatment. The overall median progression-free survival (PFS) was 9.2 months with Votrient and 4.2 months with placebo. 

For both treatment naïve patients and those who received cytokine-based treatment, the median PFS was better with Votrient – 11.1 months versus 2.8 months with placebo, and 7.4 months versus 4.2 months with placebo, respectively. The most common adverse events that occurred in greater than or equal to 20% of subjects treated with the drug included diarrhea, hypertension, hair color changes, nausea, anorexia and vomiting. 

We believe the approval of Votrient will bring with it another treatment option for patients suffering from RCC as according to the company, it is the most common malignancy of the kidney and is highly resistant to chemotherapy. It is estimated that about 57,700 people will be diagnosed with kidney cancer and 13,000 people will die from the disease in the US in 2009. 

GlaxoSmithKline had filed the candidate for FDA and EU approval for the treatment of RCC in December 2008 and March 2009, respectively. The company is also testing Votrient in combination with Tykerb. Votrient is being designed as an alternative to Pfizer’s (PFE - Analyst Report) Sutent and Bayer/Onyx’s (ONXX - Analyst Report) Nexavar.