PHILADELPHIA, March 20, 2012 /PRNewswire/ -- GlaxoSmithKline announced today that the Oncologic Drugs Advisory Committee (ODAC) to the US FDA voted 11 to 2 that evidence from clinical studies support a favourable benefit risk assessment for use of Votrient in treating patients with advanced soft tissue sarcoma who have received prior chemotherapy, noting that those with gastrointestinal stromal tumours (GIST) and adipocytic sarcomas were not included in the Phase III trial. The ODAC reviewed findings from one Phase III clinical study and one Phase II study.
“Treatment options for patients with advanced soft tissue sarcoma are limited; we are therefore pleased that the Committee took a favourable view of the clinical data for Votrient,” said Rafael Amado, Senior Vice President, GlaxoSmithKline Oncology. “We look forward to continuing the regulatory process.”
The ODAC provides FDA with independent expert advice and recommendations, however the final decision regarding approval is made by FDA.
Votrient is not approved or licensed in the US or EU for the treatment of advanced soft tissue sarcoma. For information about Votrient, including approved uses, please visit http://www.gsk.com/products/prescription-medicines/votrient.htm for full U.S. Prescribing Information including BOXED WARNING for hepatotoxicity, as well as the E.U. Patient Information Leaflet.
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
GlaxoSmithKline Enquiries: |
|
|
|
UK Media enquiries: | David Mawdsley | +44 (0) 20 8047 5502 | (London) |
| Stephen Rea | +44 (0) 20 8047 5502 | (London) |
| Sarah Spencer | +44 (0) 20 8047 5502 | (London) |
| David Daley | +44 (0) 20 8047 5502 | (London) |
|
|
|
|
US Media enquiries: | Kevin Colgan | +1 919 483 2839 | (North Carolina) |
| Melinda Stubbee | +1 919 483 2839 | (North Carolina) |
| Sarah Alspach | +1 919 483 2839 | (Washington, DC) |
| Jennifer Armstrong | +1 919 483 2839 | (Philadelphia) |
|
|
|
|
Analyst/Investor enquiries: | Sally Ferguson | +44 (0) 20 8047 5543 | (London) |
| Tom Curry | + 1 215 751 5419 | (Philadelphia) |
| Gary Davies | + 44 (0) 20 8047 5503 | (London) |
| Jeff McLaughlin | + 1 215 751 7002 | (Philadelphia) |
| Ziba Shamsi | + 44 (0) 20 8047 3289 | (London) |
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 ‘Financial review & risk’ section in the company’s Annual Report 2011 included as exhibit 15.2 to the company’s Annual Report on Form 20-F for 2011.
SOURCE GlaxoSmithKline
