GlaxoSmithKline announced that the FDA has approved Tykerb (lapatinib tablets) in combination with letrozole (Femara, from Novartis) as a first-line, all-oral regimen for the treatment of postmenopausal women with hormone receptor (HR) positive metastatic breast cancer that overexpresses the HER2 receptor. This approval was based on results from a double-blind, placebo-controlled study in 219 women diagnosed with post-menopausal, HR-positive and HER2-positive metastatic breast cancer. The data demonstrated that women treated with Tykerb and letrozole experienced a 5.2 month increase in median progression-free survival (PFS) compared to women treated with letrozole alone.

Tykerb is an oral small-molecule inhibitor of the HER2/ErbB2 tyrosine kinase receptor already indicated in combination with capecitabine, 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.

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