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The U.S. Food and Drug Administration (FDA) approved Herceptin, or trastuzumab, for treating advanced or metastatic breast cancer in September 1998. Herceptin was fast tracked for admittance for use in early stage breast cancer in the European market in early October 2005. Genentech, in South San Francisco, CA, manufactures the drug.
The drug is given intravenously and is primarily used in patients who have had little success with radiation therapy. Herceptin is also used as a first line cancer-fighting agent in patients with metastatic disease. The drug is often combined with Taxol, another cancer drug, when used for metastatic breast cancer.
Herceptin is a bioengineered antibody made from antibodies found in mice. The antibody was shaped to be more in line with human antibodies. When used effectively, Herceptin can target cancer cells and inhibit the growth of tumors. The drug has recently been seen to be effective in blocking the protein HER-2 that is responsible for about one-third of all breast cancer cases. The HER-2 protein block would then stop cancer cells from growing, and improves the immune system of women with the disease.
Herceptin's use in early stage breast cancer is seen to be highly effective. Preliminary studies have shown that its use can cut the growth of highly aggressive cancerous tumors by half if used in early stage breast cancer.
The dramatic results have been only seen in women with the HER-2 protein related breast cancer. The FDA has made it a policy to make treatments for the most serious diseases their highest priority. The drug is expected to be approved for treating early stage breast cancer in 2006 in Europe, with the US to follow.
The use of Herceptin may result in some serious side effects. Women with heart related problems might not be eligible for Herceptin treatment because the drug can weaken the heart muscle, leading to congestive heart failure. This side effect was most often seen in patients who had Herceptin combined with chemotherapy and other drugs. Herceptin is not approved for use in conjunction with cyclophosphamide (AC).
While Herceptin is currently only approved for women with advanced cases of breast cancer, doctors may also use it for earlier stages at their discretion. Whether a doctor uses the drug for early or late stage breast cancer, a full examination should be performed. The breast cancer patient should not have any other health problems, such as a heart related problem, and should be fully aware of the risks involved.
In England, a recent patient threatened to take legal action against the National Health System in order to be given the treatment for her early breast cancer. Herceptin is one of a new type of bioengineered drugs that are currently entering the market.