FDA News

FDA approves Tykerb for advanced or metastatic breast cancer

(March 14, 2007)--GlaxoSmithKline said that the United States Food and Drug Administration (FDA) approved TYKERB (lapatinib), in combination with Xeloda (capecitabine), 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 is a significant breakthrough for women with advanced HER2 (ErbB2) positive breast cancer. The data clearly show that this small molecule, oral, targeted agent, in combination with capecitabine, is effective for women whose disease has progressed on previous therapies, including anthracyclines, taxanes and trastuzumab," said Paolo Paoletti, MD, Senior Vice President of the Oncology Medicine Development Center at GSK. "The approval of TYKERB demonstrates our R&D organization’s strong commitment to the discovery and development of novel cancer treatments. We are dedicated to the further study and development of Tykerb in a variety of settings including adjuvant breast cancer as well as in other solid tumor types.”

This approval reflects more than 16 years of research, including more than 60 clinical trials and investigator-initiated collaborative research studies. 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 United States within two 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, 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."

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