Monday, GlaxoSmithKline Plc(GSK) said the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee unanimously recommended for approval its cancer drug, Votrient - pazopanib. The panel indicated the benefit-to-risk profile as acceptable for patients with advanced renal cell carcinoma. Pazopanib is an investigational, oral treatment for patients with advanced renal cell carcinoma, and is expected to prevent the growth of new blood vessels to tumors.
Rafael Amado, Vice President, GlaxoSmithKline Oncology R&D Unit said,"Kidney cancer is a very serious disease therefore the committee's recommendation in support of pazopanib is an important step towards bringing a new, oral treatment option to advanced renal cell cancer patients. We look forward to working with the FDA towards the approval of pazopanib."
According to GSK, an estimated 208,000 new cases of kidney cancer were diagnosed globally in 2002. The drug maker also indicates renal cell carcinoma as the most common type of kidney cancer that accounts for approximately nine out of ten cases.
Pazopanib has a broad clinical program across multiple tumor types. In its pivotal study, pazopanib was given orally, once daily. More than 2,000 patients have been treated to date in clinical trials. Pazopanib, however, is not yet approved in any country
GSK closed Monday's regular trading at $38.86 up $0.14 or 0.36% on a volume of 0.985 million shares on the NYSE, and in the after hours trading the stock price increased to $39.10 up $0.24 or 0.62%.
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