GSK submits Tykerb for EU approval

GlaxoSmithKline (GSK) has submitted Tykerb, a new treatment for metastatic HER-2 positive breast cancer, to the European Medicines Agency for approval.

The company’s application is for the use of Tykerb in combination with Xeloda, the Roche drug, in patients who have received prior therapy, including Herceptin.

Paolo Paoletti, senior vice president of the oncology medicine development centre at GSK, said the filing was the culmination of “many years of committed research” by GSK staff all over the world.

“This is GSK’ third European oncology filing this year, following topotecan (Hycamtin) for relapsed cervical cancer and nelarabine (Atriance) in June and we are on track for similar announcements to be made in 2007,” he stated.

He added that Tykerb has the potential to offer a “much needed alternative treatment”.

One of GSK’s main research areas is oncology, with several new products in development that are intended to strengthen the company’s foothold in the market.

In May, the UK’s largest pharmaceutical company revealed it was developing a drug to be used in conjunction with Tykerb, designed to prevent the angiogenesis process surrounding tumours, whereby the formation of blood vessels supplying the tumour is restricted.

The drug, pazopanib, is in phase I development.