WEDNESDAY, March 14 (HealthDay News) -- The U.S. Food and Drug Administration has granted approval to a new anti-cancer treatment, Tykerb (lapatinib), for use in combination with Xeloda (capectabine) for treatment of patients with advanced metastatic HER2-positive breast cancer. Women who have already been treated with other cancer drugs such as an anthracycline, a taxane, or Herceptin (trastuzumab) can be prescribed the drug.

Tykerb is a small molecule kinase inhibitor that enters cells and curbs tumor cell growth internally rather than targeting proteins on the outside of the cell. Therefore, it may benefit women with HER2-positive breast cancer that is not responding to Herceptin or other therapies.

A clinical trial of 400 women generated sufficient results to allow the drug's approval, but data on survival rates are not yet available. Side-effects include diarrhea, nausea, vomiting, rash and hand-foot syndrome.

"Today's approval is a step forward in making new treatments available for patients who have progression of their breast cancer after treatment with some of the most effective breast cancer therapies available," said Steven Galston, M.D., M.P.H., director of the FDA's Center for Drug Evaluation and Research, in a statement. "New targeted therapies such as Tykerb are helping expand options for patients."

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