FDA CLEARS GSK'S TYKERB FOR ADVANCED BREAST CANCER

GlaxoSmithKline's (GSK) kinase inhibitor Tykerb 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 approval was based on a randomized clinical trial in 400 women with advanced metastatic breast cancer that was HER2-positive. In the trial, half the patients received Tykerb with capecitabine and half received capecitabine alone. Compared with patients receiving capecitabine alone, the group receiving Tykerb with capecitabine had a statistically significant improvement in the time to tumor progression. In addition, the tumor response rate was higher in the group of patients receiving Tykerb with capecitabine (24 percent versus 14 percent). The survival data is not yet mature, according to the FDA.

The product is the first targeted, once-daily oral treatment option for the indicated patient population, GSK said. The company submitted the application for this indication in September 2006, and it is also studying the product in other cancers.