GSK submits lapatinib NDA in Japan

The Japanese unit of UK drug major GlaxoSmithKline has submitted a New Drug Application to the domestic regulator for approval to market its new cancer drug lapatinib as monotherapy and in combination with Roche's Xeloda (capecitabine) for advanced or metastatic HER2 positive breast cancer in women who have received prior therapy including an anthracycline, a taxane and Herceptin (trastuzumab). The small-molecule oral drug inhibits the tyrosine kinase components of the endothelial growth factor receptor (EbB1) and the HER2 (ErbB2) receptor. Stimulation of these is associated with cell proliferation and with multiple processes involved in tumor progression, invasion and metastases, GSK noted, adding that their overexpression has been reported in a variety of human tumors and is associated with poor prognosis and reduced overall survival.