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.
“This filing is the result of many years of tremendous research and development work by the scientists at GSK. 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, senior vice president of the oncology medicine development center at GSK.
GSK plans to submit the Marketing Authorization Application for Tykerb in Europe during the 4th quarter of this year.