FDA Panel Backs Glaxo’s Votrient

GlaxoSmithKline (GSK - Analyst Report) received positive news yesterday when the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted unanimously in favor of the company’s experimental kidney cancer drug, Votrient (pazopanib).

Importantly, the panel voted that Votrient can benefit patients by slowing the disease, despite some risk of liver damage. We believe the company may be asked to submit data from ongoing studies to ensure that liver toxicity associated with the use of the drug does not increase over time.

Votrient is an oral vascular endothelial growth factor (VEGFr) anti-angiogenesis agent. GlaxoSmithKline is seeking FDA approval for the use of Votrient as a treatment for patients with advanced renal cell carcinoma (RCC).

Phase III data showed that the drug significantly increased progression free survival compared to placebo. Glaxo filed the candidate for FDA and E.U. approval for the treatment of RCC in December 2008 and March 2009, respectively. Glaxo is also testing Votrient in combination with Tykerb. Votrient is being designed as an alternative to Pfizer’s (PFE - Analyst Report) Sutent and Bayer’s/Onyx’s (ONXX - Analyst Report) Nexavar.

According to Glaxo, RCC is the most common type of kidney cancer and accounts for approximately nine out of ten cases. 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 United States in 2009. In 2002, an estimated 208,000 new cases of kidney cancer were diagnosed globally.

A response from the FDA should be out later this month. While the agency is not required to follow the advice of the panel, it usually does so. We are currently modeling the product launch in 2010.