FDA Approves GSK’s Tykerb for Breast Cancer

GlaxoSmithKline has received approval from the FDA for Tykerb in combination with Xeloda for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. It is the first targeted, once-daily oral treatment option for this patient population. Tykerb was granted Priority Review by the FDA in November 2006.

Tykerb inhibits two validated targets in oncology, the kinase components of the EGFR (ErbB1) and HER2 (ErbB2) receptors, commonly associated with cancer cell proliferation and tumor growth. As a targeted therapy, Tykerb is designed to interfere with discrete cellular processes or disease mechanisms prevalent in cancer. Tykerb will be available in the U.S. in the next couple of weeks and, as an oral therapy, offers added convenience for patients.

“The approval of Tykerb is an important milestone in our commitment to become a major oncology company that focuses on scientific innovation and genuine patient needs,” said Chris Viehbacher, GSK’s president, U.S. Pharmaceuticals.