GlaxoSmithKline Receives Unanimous FDA Panel Approval Recommendation for VOTRIENT(TM)

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.

About pazopanib
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:
VOTRIENT(TM) is the proposed registered trademark to be used in the United
States and Europe.

Enquiries:
UK Media enquiries: Philip Thomson (020) 8047 5502
Stephen Rea (020) 8047 5502
Alexandra Harrison (020) 8047 5502
Gwenan White (020) 8047 5502
Claire Brough (020) 8047 5502

US Media enquiries: Nancy Pekarek (919) 483 2839
Mary Anne Rhyne (919) 483 2839
Kevin Colgan (919) 483 2839
Sarah Alspach (919) 483 2839

European Analyst/Investor enquiries: David Mawdsley (020) 8047 5564
Sally Ferguson (020) 8047 5543
Gary Davies (020) 8047 5503

US Analyst/Investor enquiries: Tom Curry (215) 751 5419
Jen Hill Baxter (215) 751 7002

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.

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SOURCE GlaxoSmithKline

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