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GSK Received FDA Approval for Votrient for The Treatment of Patients with Advanced STS

GlaxoSmithKline (GSK) has received FDA approval for Votrient (pazopanib) for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy.

The approval is based on the results of the randomized, double-blind, placebo controlled Phase III study called PAzopanib ExpLorEd in sofT Tissue sarcoma (PALETTE).

GSK Oncology president Paolo Paoletti said the treatment options represent the one of the few new medical options to be provided to patients with advanced soft tissue sarcoma over the last thirty years.

"GSK Oncology feels fortunate to have collaborated with the European Organization for Research and Treatment of Cancer (EORTC) in completing a rigorous Phase III trial in such a rare cancer," Paoletti added.

The efficacy of VOTRIENT for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors has not been demonstrated.

Soft tissue sarcomas constitute a group of rare cancers arising from mesenchymal cells.

 

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/gsk-wins-fda-approval-for-votrient-cancer-drug-270412
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GSK Wins FDA Approval for Votrient Cancer Drug