FDA Approves Glaxo's (GSK) TYKERB in Combination With Xeloda for the Treatment of Advanced or Metastatic Breast Cancer

March 13, 2007 3:34 PM EDT

UPDATE - GlaxoSmithKline plc (NYSE: GSK) announced today that the United States Food and Drug Administration (FDA) approved TYKERB (lapatinib), 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.

"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, President, US Pharmaceuticals at GSK. "Our rich pipeline of oncology medicines underscores our commitment to cancer patients. This commitment extends to programs to help ensure that women who may benefit from TYKERB will have access to it."

GlaxoSmithKline has confirmed that its new treatment TYKERB will be available through Commitment to Access, the company's program that provides low income patients with access to GSK products used in an outpatient setting in the United States.

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