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GEN News Highlights : Apr 27, 2012

GSK’s Votrient Approved in U.S. for Treating Soft Tissue Sarcoma

Label states efficacy hasn’t been demonstrated for treating adipocytic STS or GIST.

FDA approved GlaxoSmithKline’s Votrient® for treating patients with advanced soft tissue sarcoma who have received prior chemotherapy. Clearance was based on data from the Phase III Palette study. The drug’s label states that efficacy of Votrient for treating adipocytic STS or gastrointestinal stromal tumors hasn’t been demonstrated.

Votrient was approved in the U.S. for treating adult patients with advanced renal cell carcinoma in 2009. Conditional marketing approval for the equivalent indication was granted in the EU in 2010. Sales of Votrient reached £100 million in 2011, up from £38 million in 2010, when the drug had only just been launched in the EU. In its annual review for 2011, GSK said Votrient had achieved an 18% total prescription share in the U.S. advanced renal cell carcinoma market.

The multikinase angiogenesis inhibitor is separately undergoing Phase III development as maintenance therapy for ovarian cancer and as an adjuvant therapy for renal cell cancer. An eye drop formulation of the active ingredient, pazopanib, is in addition being evaluated in Phase II trials as a treatment for age-related macular degeneration.