Herceptin was first approved by the FDA in 1998 to treat metastatic breast cancer (cancer that's spread to other areas of the body). This latest approval means it can also be used to treat women with cancer that was detected only in the breast or lymph nodes and was surgically removed. The drug should only be given to women with HER2-positive breast cancer, the FDA said.
This expanded use is based on the findings of two studies sponsored by the US National Cancer Institute. The studies, which included nearly 4 000 women, found that 87 percent of women who received the drug and chemotherapy after surgery were cancer-free after three years, compared to 75 percent of those who received chemotherapy alone.
It's too early to determine whether Herceptin combined with chemotherapy will increase the cure rate or lower the risk of death from breast cancer, the FDA said. – (HealthDayNews)
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