GSK announces positive vote of the panel of the FDA for pazopanib in certain advanced soft tissue sarcoma
London, March 2012.- GlaxoSmithKline has announced that the Advisory Committee of oncological drugs (ODAC) of the FDA in the United States.UU. they voted 11 to 2, that the evidence from clinical studies support a favourable assessment of the beneficio-riesgo for the use of Votrient in the treatment of patients with advanced soft tissue sarcoma who have received chemotherapy before, pointing out that those with tumors of the stroma gastrointestinal (GIST) and adipocÃticos sarcomas were not included in the phase III trial. The ODAC reviewed the conclusions of a phase III clinical study and a phase II study.
“Treatment options for patients with soft tissue sarcoma are limited, therefore we are pleased that the Committee has given a favourable opinion on Votrient clinical data,” said Rafael Amado, GlaxoSmithKline Oncology Vice President Sénior “look forward to continuing the regulatory process ”.
“The ODAC provides the FDA recommendations of independent experts and advice, however the final decision on approval is made by the FDA.
Votrient is not approved or authorized in the United States.UU. or the EU for the treatment of soft tissue sarcoma. For information on Votrient, including approved indications, see the tab technical Votrient, available here.
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