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Issued – Friday 25 April 2008, London, UK

GlaxoSmithKline (GSK) announced today that the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a revised positive opinion confirming the positive benefit-risk profile for Tyverb^® (lapatinib), GSK’s new oral treatment for breast cancer. The positive opinion recommends grant of a conditional marketing authorisation.

The CHMP previously issued a positive opinion for lapatinib in December 2007. The revised positive opinion has been issued following review by the CHMP of new data received in February 2008 from GSK arising from a standard pharmacovigilance evaluation of clinical trial and post-marketing data.¹ The CHMP has confirmed that these data do not essentially change the positive benefit-risk profile for lapatinib in its proposed indication.

Upon grant of the conditional marketing authorisation by the European Commission, lapatinib, in combination with capecitabine, will be indicated for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2). Patients should have progressive disease following prior therapy which must include anthracyclines, taxanes and therapy with trastuzumab in the metastatic setting.²

It is expected that lapatinib will receive the conditional marketing authorisation from the European Commission in the coming months.

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