FDA Approves Lapatinib/Capecitabine for Advanced Breast Cancer Subgroup

The US Food and Drug Administration (FDA) approved lapatinib (Tykerb), in combination with capecitabine (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 (Herceptin). It is the first targeted, once-daily oral treatment option for this patient population. Lapatinib was granted priority review by the FDA in November 2006.

'Significant Breakthrough'

"Tykerb is a significant breakthrough for women with advanced HER2 (ErbB2)-positive breast cancer," said Paolo Paoletti, MD, senior vice president of the Oncology Medicine Development Center at GlaxoSmithKline, the drug's manufacturer. "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. . . . 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. As a targeted therapy, lapatinib is designed to interfere with discrete cellular processes or disease mechanisms prevalent in cancer. As an oral therapy, lapatinib offers added convenience for patients.