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news.UK company GlaxoSmithKline has submitted a new drug application to the Japanese authorities for approval to market Tykerb, its new breast cancer drug.
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The indication for which the company seeks approval is for both monotherapy and for combination treatment with Roche's chemotherapy drug Xeloda. The drug will be used in patients with advanced or metastatic HER2 positive breast cancer who have received prior therapy including an anthracycline, a taxane, and trastuzumab.
Marketing applications for Tykerb have been filed around the world, including the European Union, Switzerland, Canada, Brazil, Australia, and South Korea.
Tykerb inhibits the tyrosine kinase components of the EGFR (ErbB1) and HER2 (ErbB2) receptors. Stimulation of EGFR (ErbB1) and HER2 (ErbB2) is associated with cell proliferation and with multiple processes involved in tumor progression, invasion, and metastases. Overexpression of these receptors has been reported in a variety of human tumors and is associated with poor prognosis and reduced overall survival.