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Combination of TYKERB(R) (lapatinib) Plus Letrozole Demonstrated Significant Improvement in Delaying Disease Progression for HER2+/ErbB2+ Post-Menopausal Metastatic Breast Cancer
Date:12/11/2008

static breast cancer. Women in the study were randomized to compare the efficacy of first-line therapy with lapatinib, a small-molecule tyrosine kinase inhibitor, and the aromatase inhibitor letrozole versus letrozole monotherapy. At randomization patients received either letrozole 2.5 mg once daily (QD) plus lapatinib 1500 mg QD, or letrozole 2.5 mg QD plus placebo. The primary endpoint of EGF30008 was PFS in the HR+/HER2+/ErbB2+ population, and secondarily in the overall ITT population. Secondary endpoints included overall response rate (ORR), clinical benefit rate (CBR), time to response, duration of response, overall survival, safety assessments and quality of life. Hormonal therapy was allowed in the adjuvant setting only (1 year prior to study entry) and crossover was not permitted.

About 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 is approved in 63 countries. On March 13, 2007, the United States Food and Drug Administration (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 adopted a decision to grant a conditional marketing authorization for lapatinib in all 27 European Union (EU) member states. Other countries include Australia, India, Brazil, Russia, Turkey, South Korea, Taiwan and others around the world. Registration dossiers for lapatinib have been filed in Canada, China, Japan, Mexic
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SOURCE GlaxoSmithKline
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