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GSK submits Votrient for ovarian cancer in Europe

Pharma company hopes for extra indication for oncology product

GSK GlaxoSmithKline house

GlaxoSmithKline (GSK) has attempted to expand the use of its cancer drug Votrient, submitting it for European approval in the treatment of cancers that affect women.

The pharma company is looking for approval from the European Medicines Agency (EMA) for the use of Votrient (pazopanib) in women with ovarian, fallopian tube or primary peritoneal cancer who have not progressed after receiving first-line chemotherapy.

If passed, the approval would add to existing indications for Votrient that cover advanced renal-cell carcinoma and certain forms of soft-tissue sarcoma.

“This EU filing, the third for pazopanib in less than five years, confirms GSK's commitment to deliver our oncology pipeline,” said Dr Rafael Amado, head of oncology R&D, GSK, who also confirmed that the company was working on submission plans for other countries throughout the world.

Votrient has been one of GSK's more successful new launches, making £150m during the first six months of 2013 – a solid performance considering it was only approved for sarcoma in August last year and had been under conditional approval in Europe for renal-cell carcinoma until last month.

GSK's has larger ambitions though, and is keen to enter an ovarian cancer market that is set to grow from $460m in 2011 to $1.4bn in 2012, with ovarian cancer the fifth leading cause of cancer death among women in developed countries.

To do this, Votrient will have to compete with other drugs on the market, including angiogenesis inhibitors such as Amgen's AMG-386 (currently in phase III development) and Roche's Avastin (bevacizumab), which gained the extra indication in late 2012.

Instead, Votrient is a protein-kinase inhibitor and works by blocking enzymes found in some receptors on the surface of cells that are involved in the growth and spread of cancer cells.

It has shown positive results in phase III trials, however, delaying disease progression for a median of 17.9 months compared with 12.3 months among people on placebo during a study of 940 patients with advanced ovarian, fallopian tube and primary peritoneal cancer.

Article by
Thomas Meek

8th August 2013

From: Sales



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