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FDA Approves Wider Herceptin Use for Early Breast Cancer

Herceptin-chemo combination yields 87 percent three-year disease-free survival, versus 75 percent for chemotherapy alone

MONDAY, Nov. 20 (HealthDay News) -- The U.S. Food and Drug Administration has approved broader use of the biological drug Herceptin (trastuzumab) for early-stage breast cancer. Herceptin is now approved for use in combination with other chemotherapy drugs against HER2-positive breast cancer after lumpectomy or mastectomy in women with non-metastatic cancer.

The drug was initially approved in 1998 for HER2-positive breast cancer that had metastasized.

The FDA approval came after two clinical trials by the National Cancer Institute of 4,000 breast cancer patients found that women treated with conventional chemotherapy plus Herceptin after surgery had fewer relapses for up to three years after surgery than patients on standard chemotherapy.

Disease-free survival rates were 87 percent at three years for women on combination therapy, versus 75 percent for chemotherapy only. It is too soon to calculate cure rates, the FDA states.

"This is especially good news for women who have breast cancer caused by excessive amounts of the HER2 protein because this cancer typically has a poor prognosis," Steven Galson, M.D., M.P.H., director of the FDA's Center for Drug Evaluation and Research, said in a statement.

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