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FDA Approves Tykerb for Advanced Breast Cancer

March 13, 2007--The FDA has approved Tykerb (lapatinib) to be used in combination with capectabine (Xeloda) for patients with advanced, metastatic breast cancer that is HER2 positive. The combination treatment is indicated for women who have received prior therapy with other cancer drugs, including an anthracycline and trastuzumab (Herceptin). 

Tykerb is a kinase inhibitor that works through multiple pathways to deprive tumor cells of signals needed to grow. Whereas trastuzumab is a monoclonal antibody that targets the part of the HER2 protein on the outside of the cell, Tykerb is a small molecule that enters the cell and blocks the function of this and other proteins. Due to this difference in mechanism of action, Tykerb works in some HER2-positive breast cancers that have been treated with trastuzumab and are no longer benefiting. 

Tykerb will be distributed by GlaxoSmithKline. FDA News

 

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