GSK receives EU marketing authorisation for Tyverb

GlaxoSmithKline (GSK) has announced that it has received marketing authorisation in the EU for Tyverb (lapatinib) as a treatment for breast cancer.

The orally-administered small molecule dual target therapy has been approved by the European Commission as a treatment for patients with advanced or metastatic breast cancers whose tumours overexpress ErB2 (HER2).

For patients to be suitable for this treatment, they should have progressive disease after previous therapy including anthracyclines, taxanes and trastuzumab in the metastatic setting.

Lapatinib has an innovative mechanism of action and works by inhibiting the tyrosine kinase components of the ErbB1 and ErbB2 receptors after getting inside cancer cells.

Professor David Cameron, director of the National Cancer Research Network, said: “Today?s news will benefit women across Europe with HER2-positive advanced or metastatic breast cancer which needs further treatment after the previous standard treatments of anthracyclines, taxanes, and trastuzumab.”

He added that the compound will play a key role in treating this aggressive form of advanced breast cancer while offering patients the convenience of a pill rather than injections.

In May 2008, GSK announced positive phase III results for the use of Tyverb plus Herceptin (trastuzumab) as a treatment for HER2-positive metastatic breast cancer.