GlaxoSmithKline submits application to expand Votrient use

GlaxoSmithKline is applying to European and US healthcare regulators to expand the indicated applications of its cancer therapy Votrient.

The company has submitted an application to the European Medicines Agency to expand its marketing authorisation application to include patients with advanced soft tissue sarcoma that cannot benefit from chemotherapy.

Votrient is not currently approved anywhere in the world for the treatment of this condition, with a similar submission having also been made to the US Food and Drug Administration in the same specification.

These applications are supported by data from a phase III study among a soft tissue sarcoma population, which excluded patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumours.

Votrient is primarily indicated as a treatment for advanced renal cell carcinoma and has been clinically proven to be safe and efficacious.

It was made available to NHS patients in England, Wales and Scotland earlier this year following recommendations from the National Institute for Health and Clinical Excellence and the Scottish Medicines Consortium.