GlaxoSmithKline is looking to get extended approval on both sides of the Atlantic for its kidney cancer drug Votrient to be also used for soft tissue sarcoma.
Specifically, the UK drugs major 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 unsuited for the latter. A supplemental New Drug Application for pretty much the same indication has been filed with the US Food and Drug Administration.
The filings are based on a Phase III trial which excluded patients with adipocytic soft tissue sarcoma (liposarcoma) or gastrointestinal stromal tumour.
Votrient, a once-daily, oral angiogenesis inhibitor, was approved in the USA in October 2009 for advanced kidney cancer and got a conditional green light in that indication from the European Medicines Agency in June 2010. The compound is being studied in a number of other diseases, notably ovarian, breast and non small-cell lung cancer, as well as for age-related macular degeneration.