Announcement signals a new way to treat advanced or metastatic ErbB2 (HER2)-positive breast cancer

 GlaxoSmithKline (GSK) announced today that Tyverb® (lapatinib) has received a positive opinion recommending a conditional marketing authorisation from the European Medicines Agency (EMEA). Lapatinib, in combination with capecitabine, is indicated for the treatment of patients with advanced or metastatic breast cancer whose tumours over-express ErbB2 (HER2). Patients should have progressive disease following prior therapy which must include anthracyclines, taxanes and therapy with trastuzumab in the metastatic setting. Lapatinib is the first oral, small molecule dual targeted therapy that works by getting inside the cancer cell to inhibit both ErbB1 (EGFR) and ErbB2 (HER2), two receptor proteins which are responsible for tumour growth. This novel mechanism of action is a new way to treat breast cancer. "This positive opinion is fantastic news for eligible women with ErbB2-positive breast cancer across the European Union. Thousands of women are diagnosed every year in Europe with ErbB2 positive breast cancer and are at a greater risk of disease progression and death compared to women with tumours that do not over-express this protein,” said Dr Martine Piccart, Professor of Oncology, Université Libre de Bruxelles and Department Head, Medicine, Jules Bordet Institute, Brussels. “Lapatinib represents an important new treatment option for a group of patients in real need of alternative therapies and I look forward to the day that I can prescribe lapatinib. Not only that, but this is just the beginning given the ongoing clinical programme investigating the potential use of lapatinib in earlier stages of the disease.” The positive opinion was based on a pivotal Phase III trial (EGF100151) in which women with advanced or metastatic ErbB2-positive breast cancer, whose disease had progressed following prior treatment, were given either the combination of lapatinib and capecitabine, or capecitabine alone. The data showed that the analysis of investigator reported median time to progression (TTP) was 23.9 weeks in the lapatinib and capecitabine arm versus 18.3 weeks in the capecitabine arm alone. Significance was also shown in the independently assessed time to progression data. In addition to the achievement of the primary endpoint, results from the trial demonstrated the associated potential to reduce the incidence of brain metastases as the first site of recurrence in metastatic breast cancer. Progression of brain metastases was 2% in the combination arm compared with 6% in the capecitabine alone arm. Central nervous system metastases are a major burden for breast cancer patients. These preliminary results with lapatinib are encouraging and are the basis of ongoing research in this area. Latest data on the use of lapatinib and capecitabine in brain metastases will be presented at the San Antonio Breast Cancer Symposium (SABCS) on 16 December 2007. The most common adverse events during therapy with lapatinib plus capecitabine were gastrointestinal (diarrhoea, nausea and vomiting) or skin disorders (rash and hand and foot syndrome). The majority of adverse events were mild to moderate in severity and were not significantly higher than those seen with capecitabine monotherapy. "This is an extremely significant development for patients and physicians across Europe as lapatinib, in combination with capecitabine, will play a valuable role in treating an especially aggressive form of advanced breast cancer by providing an effective treatment that offers added convenience as an oral therapy," said Paolo Paoletti, SVP and Global Head of the Oncology Medicine Development Centre at GSK. Andrew Witty, President, Pharmaceuticals Europe, GSK and CEO designate added, "The innovative mechanism of action of lapatinib represents a new way to treat breast cancer patients. It is also importa