PHILADELPHIA and LONDON, Sept. 18 /PRNewswire-FirstCall/ -- GlaxoSmithKline plc (NYSE: GSK; London) today announced the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for approval to market Tykerb® (lapatinib ditosylate), in combination with Xeloda® (capecitabine), for the treatment of advanced or metastatic HER2 (ErbB2) positive breast cancer in women who have received prior therapy, including Herceptin® (trastuzumab). The compound has been granted Fast Track status by the FDA in this patient population. TYKERB is a small molecule dual kinase inhibitor developed by GSK as an oral therapy, and is currently being investigated in breast cancer and other solid tumors. TYKERB is an investigational drug and has not been approved for marketing by any regulatory body.
