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| |  Lapatinib Approved in Europe for Breast Cancer LONDON -- June 13, 2008 -- The European Commission has granted a conditional marketing authorisation for lapatinib (Tyverb) for all 27 European Union (EU) member states. Lapatinib, in combination with capecitabine, is 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 and taxanes, and therapy with trastuzumab in the metastatic setting. Lapatinib has a novel mechanism of action. It is a small molecule that is administered orally and inhibits 2 receptor proteins -- the tyrosine kinase components of the ErbB1 and ErbB2 receptors. The signalling of these receptors is responsible for tumour growth and proliferation. Authorisation was based on a pivotal phase 3 trial in which women with locally advanced or metastatic ErbB2-positive breast cancer whose disease had progressed following prior treatment with anthracyclines, taxanes, and trastuzumab were given either the combination of lapatinib and capecitabine, or capecitabine alone. The data showed that the investigator-assessed median time to progression was 5.5 months in the lapatinib and capecitabine arm versus 4.2 months in the capecitabine-only arm. The independent assessment demonstrated that lapatinib, when given in combination with capecitabine, significantly increased time to progression by 6.2 months compared with 4.3 months with capecitabine alone. The most common adverse events during therapy with lapatinib plus capecitabine were gastrointestinal or skin disorders. Diarrhoea and rash were more common with the combination than with capecitabine alone. The majority of adverse events were mild to moderate in severity, and the incidence of grade 3 and 4 events was low and similar in both treatment groups. Lapatinib has also been associated with reports of decreases in left ventricular ejection fraction, pulmonary toxicity, and hepatotoxicity. "Today's news will benefit women across Europe with HER2-positive advanced or metastatic breast cancer that needs further treatment after the previous standard treatments of anthracyclines, taxanes, and trastuzumab. Lapatinib will play a valuable role in treating this especially aggressive form of advanced breast cancer, with the added benefit of convenience being a pill rather than needing intravenous administration," said David Cameron, MD, Co-Principle Investigator of the phase 3 trial, National Cancer Research Network, University of Leeds, Leeds, United Kingdom. A comprehensive clinical development programme is evaluating lapatinib both alone and in combination with other therapies across the spectrum of HER2-positive breast cancer, from metastatic to early breast cancer. Trials are also ongoing and planned in a range of other solid tumours that overexpress ErbB1 and/or ErbB2, including gastric and head and neck cancer. SOURCE: GlaxoSmithKline
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