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GSK gets European marketing authorisation for pazopanib to treat certain advanced soft tissue sarcoma subtypes

London, UKWednesday, August 8, 2012, 14:00 Hrs  [IST]

The European Commission has granted marketing authorisation for GlaxoSmithKline's pazopanib (Votrient) for the treatment of patients with advanced soft tissue sarcoma (aSTS) who have received prior chemotherapy or have progressed within 12 months after (neo) adjuvant therapy. Efficacy and safety has only been established in certain STS histological tumour subtypes.

“The approval of Votrient for this diverse group of tumours marks progress for patients who have seen few new treatment options in decades,” said Dr. Paolo Paoletti, president, GSK Oncology.  “GSK is very pleased that our collaborative effort with the European Organization for Research and Treatment of Cancer (EORTC) allowed us to address the research challenges thus enabling us to bring a new treatment option to European patients.”

Soft tissue sarcomas constitute a group of rare cancers arising from mesenchymal cells. These cells normally give rise to soft tissues including fat, muscle, nerve, blood vessels and other connective tissues. In Europe, it is estimated that soft tissue sarcoma (STS) represents an average of 5 out of 100,000 new cancer diagnoses a year.

In the European Union (EU), Votrient is now approved for use in adult patients with subtypes of advanced Soft Tissue Sarcoma who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy.  Efficacy and safety has only been established in certain STS histological tumour subtypes.

Votrient is also approved in the EU as first line treatment of advanced Renal Cell Carcinoma (RCC) in adults, including those who have received prior cytokine therapy for advanced disease.

 
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