Issued: Wednesday 06 July 2011, London UK and Philadelphia, PA

GlaxoSmithKline (GSK) announced today that it has submitted a variation to the Marketing Authorisation Application to the European Medicines Agency for Votrient (pazopanib) for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy, or for patients who are unsuited for such therapy. 

Additionally, GSK announced that it has submitted a supplemental New Drug Application to the US Food and Drug Administration for Votrient for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy. 

The Phase III soft tissue sarcoma trial population excluded patients with adipocytic soft tissue sarcoma (liposarcoma) or gastrointestinal stromal tumour.

Votrient is not approved or licensed anywhere in the world for the treatment of advanced soft tissue sarcoma.  For more information about Votrient , including currently licensed indications, please visit www.gsk.com/products/prescription-medicines/votrient.htm for EU Patient Information Leaflet and full US Prescribing Information including BOXED WARNING.

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