GlaxoSmithKline Announces Positive Vote from FDA Panel for Pazopanib in Certain Advanced Soft Tissue Sarcomas
GlaxoSmithKline announced today that the Oncologic Drugs Advisory Committee (ODAC) to the FDA voted 11 to 2 that evidence from clinical studies support a favorable benefit–risk assessment for use of Votrient in treating patients with advanced soft tissue sarcoma who have received prior chemotherapy.
PRESS RELEASE
GlaxoSmithKline announced today that the Oncologic Drugs Advisory Committee (ODAC) to the FDA voted 11 to 2 that evidence from clinical studies support a favorable 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 favorable 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 United States or European Union for the treatment of advanced soft tissue sarcoma. For information about Votrient, including approved uses, please visit www.gsk.com/products/prescription-medicines/votrient.htm for full United States prescribing information including a boxed warning for hepatotoxicity, as well as the European Union patient information leaflet.
SOURCE: http://www.gsk.com/media/pressreleases/2012/2012-pressrelease-991801.htm
