GlaxoSmithKline receives unanimous FDA Panel approval recommendation for Votrient
Issued: October 5, 2009, Philadelphia, PA
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 VotrientTM (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.
GSK in Oncology
GSK Oncology is dedicated to producing innovations in cancer that will make profound differences in the lives of patients. Through GSK's revolutionary ‘bench to bedside' approach, we are transforming the way treatments are discovered and developed, resulting in one of the most robust pipelines in the oncology sector. Our worldwide research in oncology includes collaborations with more than 160 cancer centers. GSK is closing in on cancer from all sides with a new generation of patient focused cancer treatments in prevention, supportive care, chemotherapy and targeted therapies.
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
Note to Editors:
VotrientTM is the proposed registered trademark to be used in the United States and Europe.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2008.