GlaxoSmithKline Receives Unanimous FDA Panel Approval Recommendation for VOTRIENT(TM)
PHILADELPHIA, Oct. 5 /PRNewswire/ — GlaxoSmithKline [NYSE: GSK] today announced that the United States Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted unanimously in support of the approval of VOTRIENT(TM) (pazopanib). Specifically, the panel voted that the benefit-to-risk profile is acceptable for patients with advanced renal cell carcinoma (RCC). Pazopanib is an investigational, oral treatment for patients with advanced RCC.
“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,” said Rafael Amado, MD, Vice President, GlaxoSmithKline Oncology R&D Unit. “We look forward to working with the FDA towards the approval of pazopanib.”
RCC is the most common type of kidney cancer and accounts for approximately nine out of ten cases. It is estimated that approximately 57,700 people will be diagnosed with kidney cancer and 13,000 people will die from kidney cancer in the United States in 2009. In 2002, an estimated 208,000 new cases of kidney cancer were diagnosed globally.
The advisory committee made its decision based on Phase III pivotal trial data that were presented at the American Society of Clinical Oncology 2009 annual meeting.
Pazopanib is an investigational medicine that may prevent the growth of new blood vessels to tumors, a process known as angiogenesis. All solid tumors need blood vessels to survive, and medicines in this category may halt the progression of tumor growth.
About pazopanib and clinical development
In its pivotal study, pazopanib was administered orally, once daily. Pazopanib has a broad clinical program across multiple tumor types, with study details available at www.clinicaltrials.gov. More than 2,000 patients have been treated to date in clinical trials.
Pazopanib is not yet approved in any country.
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Note to Editors:
VOTRIENT(TM) is the proposed registered trademark to be used in the United States and Europe.
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