Navigation Links
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 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

Note to Editors:

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

    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.

         Registered in England & Wales:
         No. 3888792

         Registered Office:
         980 Great West Road
         Brentford, Middlesex
         TW8 9GS

SOURCE GlaxoSmithKline

SOURCE GlaxoSmithKline
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Erythematosus
2. FYI From Human Genome Sciences: GlaxoSmithKline Study Shows GSKs Novel Diabetes Treatment Syncria(R) (Albiglutide) Improves Glucose Control, Reduces Weight
3. FDA Advisory Panel Makes Favorable Recommendation for GlaxoSmithKline and Genmabs ARZERRA(TM) (ofatumumab)
4. Oxford BioTherapeutics and GlaxoSmithKline Form Strategic Alliance to Develop Novel Cancer Therapeutic Antibodies
5. Idenix Pharmaceuticals and GlaxoSmithKline Sign Worldwide License Agreement for IDX899, a Novel NNRTI for the Treatment of HIV
6. Biotica Strikes Significant Collaboration Deal With GlaxoSmithKline
7. Volcanos VH(R) IVUS Technology Used in Imaging Study of GlaxoSmithKlines Novel Investigational Compound, Darapladib
8. Genmab and GlaxoSmithKline Announce Positive Top-Line Results in Ofatumumab Chronic Lymphocytic Leukemia Pivotal Study
9. GlaxoSmithKline Responds to FDA on CERVARIX(R) and Plans to Submit Final Study Data for Approval
10. GlaxoSmithKline Collaborates with National Cancer Institute to Make Large Body of Cancer Cell Genomic Data Available to All Cancer Researchers
11. GlaxoSmithKline Announces New Drug Application and Phase III Results for Rezonic(TM)/Zunrisa(TM) (Casopitant)
Post Your Comments:
(Date:11/25/2015)... 2015 Research and Markets ( ) ... - Global Forecast to 2020" report to their ... for 37.21% of the total market share in 2014. ... region is projected to growth at the highest CAGR ... primarily to the fast growing water, industrial gas treatment, ...
(Date:11/25/2015)... November 25, 2015 --> ... sie eine Lizenz für das Patent über eine neue ... und ENS-Lyon innehaben, an Enyo Pharma vergeben haben. ... ins Leben gerufenen und von Edelris gemeinsam mit seinen ... ein Behandlungsziel für HBV identifiziert, und es wurden neue ...
(Date:11/25/2015)... November 25, 2015 ... addition of the  "Global Drug Device ... to their offering.  --> ... of the  "Global Drug Device Combination ... their offering.  --> Research ...
Breaking Medicine Technology:
(Date:11/24/2015)... Florida (PRWEB) , ... November 25, 2015 , ... ... planning and monitoring. Their Care Plan software creates an agreement between the ... patient care plan, including financial, scheduling, monitoring, notification, and projections. Click ...
(Date:11/24/2015)... ... 24, 2015 , ... Eric C. Seidel, DMD and Stephanie ... the revolutionary BIOLASE WaterLase iPlus 2.0™ system. This advanced laser technology uses light ... dentist in Gettysburg, PA . From routine visits to cosmetic treatments, laser ...
(Date:11/24/2015)... ... ... Dr. Todd S. Afferica, a noted general dentist in Norcross, GA ... Afferica now uses the BIOLASE WaterLase iPlus 2.0™ in many of his dental procedures. ... traditional cutting tools, such as the scalpel and high-speed drill, which can both cause ...
(Date:11/24/2015)... Mississauga, ON (PRWEB) , ... November 24, 2015 , ... ... Deborah Williams without a referral for dental implants at her Mississauga, ON ... qualified and experienced in the placement of dental implants. , Missing teeth can ...
(Date:11/24/2015)... ... November 24, 2015 , ... Young patients with a wide variety ... Wolfman and Dr. Kedar S. Lele, who are pediatric dentists in Tucson, AZ ... the WaterLase iPlus 2.0™ system causes minimal discomfort and bleeding to the patient during ...
Breaking Medicine News(10 mins):