GlaxoSmithKline seeks an FDA approval to market Tykerb (lapatinib ditosylate), for the treatment of advanced or metastatic breast cancer in
women.

TYKERB, the result of tremendous research, 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.

"It is truly an outstanding milestone, especially for the many thousands of women who are facing the devastating effects of advanced breast cancer," said Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Center at GSK.

"Many of these women are desperately in need of alternative treatments, and this filing demonstrates that we have turned the corner toward a new era of targeted agents."

During the study, 324 women who had advanced or metastatic breast cancer with documented HER2 overexpression and whose disease progressed
following treatment with Herceptin and other cancer therapies, were treated with TYKERB and Xeloda or Xeloda alone. In this pivotal trial, the combination of TYKERB and Xeloda (capecitabine), versus Xeloda alone. The new breast cancer drug nearly doubled median time to progression.

The most common adverse events during therapy with TYKERB plus Xeloda were mild to moderate gastrointestinal (diarrhea, nausea, and vomiting) or dermatologic (palmer-plantar erythrodysesthesia and rash).