GSK breast cancer drug gets first European approval

GlaxoSmithKline (GSK) has announced the granting of approval from the Swiss regulatory authorities for the firm’s orally-administered breast cancer treatment Tyverb (lapatinib).

The company forecasts that – pending further approval – the compound will be rolled out across the rest of Europe during the second half of 2007.

Lapatinib is a small molecule that has a novel mode of operation, inhibiting the tyrosine kinase components of the ERbB1 and ErbB2 receptors – receptor proteins responsible for the growth of tumours.

Approval for the compound was based on a phase III trial showing median time to progression in patients treated with a lapatinib and capecitabine combination of 27.1 weeks with a response rate of 23.7 per cent.

This compares to 18.6 weeks time to progression and response rate of 13.9 per cent in patients treated solely with capecitabine.

Paolo Paoletti, senior vice-president and global head of the oncology medicine development centre at GSK, said: “Lapatinib offers patients an effective, well-tolerated treatment and as an oral therapy offers added convenience for patients.

“The approval of lapatinib demonstrates our [research and development] organisation’s strong commitment to the discovery and development of novel cancer treatments.”

He added that the company was committed to efforts to further develop lapatinib in other types of cancer and earlier stages of breast cancer.

In March 2007, GSK announced the launch of a phase III clinical trial investigating the use of Tyverb as a treatment for squamous cell carcinoma of the head and neck.