PHILADLEPHIA—GlaxoSmith-Kline (GSK) has announced the submission of a New Drug Application to the US Food and Drug Administration (FDA) for approval to market Tykerb (lapatinib ditosylate), in combination with capecitabine(Drug information on capecitabine) (Xeloda), for the treatment of advanced or metastatic HER2-positive breast cancer in women who have received prior therapy, including trastuzumab(Drug information on trastuzumab) (Herceptin). The company has been granted Fast Track status by the FDA in this patient population. Tykerb, an oral small-molecule dual-kinase inhibitor, is currently being investigated in breast cancer and other solid tumors.
The filing is based on a planned interim analysis of the phase III international, multicenter, open-label trial presented at ASCO 2006 (see ONI June 2006, page 1). The trial included 324 women with advanced or metastatic breast cancer with documented HER2 overexpression and whose disease progressed following treatment with Herceptin and other cancer therapies. They were randomized to receive Tykerb/Xeloda or Xeloda alone. The results showed that median time to progression was 8.5 months with the combination vs 4.4 months with Xeloda alone (P = .00008).
"This filing is the result of many years of tremendous research and development work by the scientists at GSK," said Paolo Paoletti, MD, senior vice president at GSK's Oncology Medicine Development Center. "It is truly an outstanding milestone, especially for the many thousands of women who are facing the devastating effects of advanced breast cancer. Many of these women are desperately in need of alternative treatments, and this filing shows that we have turned the corner toward a new era of targeted agents."
