FDA APPROVES NEW DRUG FOR ADVANCED BREAST CANCER

GlaxoSmithKline's (GSK) kinase inhibitor Tykerb has gained FDA approval for use in combination with Roche's oral chemotherapeutic Xeloda for the treatment of advanced metastatic breast cancer — specifically in tumors that produce an excess of the HER2 protein.

Tykerb (lapatinib) is indicated for use in the second-line treatment setting for patients previously treated with Genentech's Herceptin (trastuzumab), taxanes or an anthracycline, the FDA said.

GSK will support the product launch with a call center that offers patients help in securing reimbursement, as well as information for physicians, the firm said. GSK said it will launch Tykerb within two weeks.

The product is the first targeted, once-daily, oral treatment option for the indicated patient population, GSK said. The company is also studying the product in other cancers, including head and neck cancers, as well as other breast cancer settings.