New Breast Cancer Drug Tykerb From Glaxo May Be Within Months In EU

Glaxo is set to file for EU approval of it's new breast cancer drug Tykerb, reports The Observer.

While the source is not named in the report, it says that unlike Swiss made Herceptin - which is administered intravenously - the breast cancer drug Tykerb from GSK offers a significant advance in treatment because women can swallow one pill a day at home.

Recently GSK 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).

From the press release we learn the following about the breast cancer drug Tykerb:

Tykerb, a small molecule that is administered orally, inhibits the tyrosine kinase components of EGFR (ErbB1) and HER2 receptors. Stimulation of EGFR and HER2 is associated with cell proliferation and with multiple processes involved in tumor progression, invasion, and metastases. Overexpression of these receptors has been reported in a variety of human tumors and is associated with poor prognosis and reduced overall survival.

GSK is using advanced technologies, including pharmacogenetics, to better define patient populations that may respond to Tykerb.

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.