GlaxoSmithKline Withdraws EU Application for Votrient as a Maintenance Therapy for Advanced Ovarian Cancer

GlaxoSmithKline plc has withdrawn its application to the European Medicines Agency (EMA) for a variation to the marketing authorization for Votrient® (pazopanib). This application, made in August 2013, was related to the additional indication for the maintenance treatment of women with FIGO stage II-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer who had not progressed after receiving first-line chemotherapy.

GSK has taken the decision because the data from the planned second interim overall survival analysis of the Phase III study did not support the overall benefit/risk for Votrient in this indication.

Votrient was first approved by FDA for the treatment of patients with advanced renal cell carcinoma in October 2009 and received conditional marketing authorization in the European Union (EU) in June 2010. Votrient is fully approved in the EU and in more than 85 countries.

Source: GlaxoSmithKline

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