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FDA Approves GSK’s Tykerb for Breast Cancer

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By: Tim Wright

Editor-in-Chief, Contract Pharma

GlaxoSmithKline has received approval from the FDA for Tykerb in combination with Xeloda for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. It is the first targeted, once-daily oral treatment option for this patient population. Tykerb was granted Priority Review by the FDA in November 2006. Tykerb inhibits two validated targets in oncology, the kinase...

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