USFDA Approved GlaxoSmithKline's Breast Cancer Drug TYKERB®

Filed in archive Treatment on March 15, 2007

The USFDA has recently 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 (anthracycline, a taxane, and trastuzumab).

A product of GlaxoSmithKline plc (GSK), TYKERB® offers convenience to patients, being the first targeted, once-daily oral treatment option for this particular patient population.

According to Paolo Paoletti, MD, Senior Vice President of the Oncology Medicine Development Center at GSK:

"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.

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."

Within two weeks (of the approval), TYKERB® will be available in the United States.

Find more details from the full report.