GlaxoSmithKline files for expanded Votrient use in USA and Europe

UK pharma giant GlaxoSmithKline (LSE: GSK) says 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 filings are based on a Phase III trial, the study population of which excluded patients with adipocytic soft tissue sarcoma (liposarcoma) or gastrointestinal stromal tumor, the company noted.