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GlaxoSmithKline Announces Data on TYKERB(R) (Lapatinib) Plus Capecitabine for the Treatment of HER2 Positive Breast Cancer Brain Metastases
Date:12/17/2007

adverse events include hand-foot syndrome (palmar-plantar eryrthrodysaesthesia) (37 percent), diarrhea (34 percent), nausea (22 percent), vomiting (12 percent), anorexia (12 percent), and nail disorder (12 percent). The most common Grade 3 adverse events include hand-foot syndrome (8 percent), nausea (8 percent), vomiting (6 percent), diarrhea (4 percent) and fatigue (2 percent).

"This trial and the ongoing clinical development program for TYKERB represent GSK Oncology's commitment to developing treatments that help improve the lives of cancer patients," said Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Center at GSK. "We plan to further study the effects of TYKERB in HER2-positive patients with brain metastases."

Brain Metastases Associated with HER2-Positive Breast Cancer

Metastatic breast cancer is the second most common type of cancer to develop brain metastases(4). Approximately 10 percent of newly diagnosed breast cancer patients have locally advanced and/or metastatic disease; 20 to 85 percent of patients (depending on initial stage, tumor biology, and treatment strategy) diagnosed with early breast cancer will develop recurrent and/or metastatic disease(5). Up to one-third of women with HER2-positive breast cancer may develop brain metastases(2).

About TYKERB/TYVERB(3)

TYKERB/TYVERB (lapatinib) is a first-in-class oral small-molecule inhibitor of the HER2 (ErbB2) tyrosine kinase receptor. Stimulation of HER2 is associated with cell proliferation and with multiple processes involved in tumor progression and metastases. Overexpression of this receptor has been reported in a variety of human tumors and is associated with poor prognosis and reduced overall survival. On March 13, 2007, the United States Food and Drug Administration (FDA) approved TYKERB, in combination with capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and
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SOURCE GlaxoSmithKline
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