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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

o 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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BOXED WARNING and Additional Important Safety Information

Hepatotoxicity - TYKERB has been associated with hepatotoxicity. Hepatotoxicity (ALT or AST >3 times the upper limit of normal and total bilirubin >1.5 times the upper limit of normal) has been observed in clinical trials (<1% of patients) and postmarketing experience. The hepatotoxicity may be severe and deaths have been reported. Causality of the deaths is uncertain. The hepatotoxicity may occur days to several months after initiation of treatment. Liver function tests should be monitored before initiation of treatment, every 4 to 6 weeks during treatment, and as clinically indicated. If changes in liver function are severe, therapy with TYKERB should be discontinued and patients should not be re-treated with TYKERB.

Decreased Left Ventricular Ejection Fraction - TYKERB has been reported to decrease LVEF. Caution should be taken if
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