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GlaxoSmithKline

GSK's TYKERB Receives Accelerated Approval for First-Line Combination Treatment of Metastatic Breast Cancer

Published in Cancer Law Weekly, February 20th, 2010

GlaxoSmithKline (NYSE:GSK) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for a new combination regimen using TYKERB® (lapatinib) as a first-line, all-oral treatment for women with metastatic breast cancer.

TYKERB is now indicated in combination with letrozole for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.

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