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GSK Submits TYVERB(R)/TYKERB(R) (lapatinib) for First-Line Treatment of Metastatic Breast Cancer in Europe, US
Date:4/1/2009

cancer."

About TYVERB(R)/TYKERB(R) (lapatinib)

Lapatinib is an oral small-molecule inhibitor of the HER2/ErbB2 tyrosine kinase receptor. Stimulation of HER2/ErbB2 is associated with cell proliferation and with multiple processes involved in tumor progression and metastases. Overexpression of these receptors has been reported in a variety of human tumors and is associated with poor prognosis and reduced overall survival.

Lapatinib, in combination with capecitabine, is approved in 74 countries. On March 13, 2007, the U.S. FDA approved lapatinib in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2/ErbB2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. On June 10, 2008, the European Commission granted a conditional marketing authorization for lapatinib in all 27 European Union (EU) member states. Other countries in which lapatinib is approved for marketing include Australia, India, Brazil, Russia, Switzerland, Turkey, South Korea, Taiwan and others around the world. Registration dossiers for lapatinib have been filed in Canada, China, Japan, Mexico and a number of countries in Latin America, Middle East, Africa and Asia Pacific.

GSK in Oncology

GSK Oncology is dedicated to producing innovations in cancer that will make profound differences in the lives of patients. Through GSK's revolutionary 'bench to bedside' approach, we are transforming the way treatments are discovered and developed, resulting in one of the most robust pipelines in the oncology sector. Our worldwide research in oncology includes collaborations with more than 160 cancer centers. GSK is closing in on cancer from all sides with a new generation of patient-focused cancer treatments in prevention, supportive care, chemotherapy and targeted therapies.


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SOURCE GlaxoSmithKline
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