Congrats to BMY holders .. a new FDA for you ,,
>>Herceptin is indicated for initial treatment of patients in combination with paclitaxel -- a drug originally derived from the Pacific Yew tree -- and by itself for those who already have undergone other cancer therapy. Paclitaxel is sold under the name Taxol by Bristol-Myers Squibb Co. <BMY.N> <<
That is CYPH's synthetic Taxol .. CYPH delivery is much cheaper ,,
U.S. FDA approves Herceptin for breast cancer
By Michael Fitzpatrick
LOS ANGELES, Sept. 25 (Reuters) - The U.S. Food and Drug Administration (FDA) approved a new drug for breast cancer on Friday, the first drug that uses a gene-based treatment to attack the disease.
Herceptin, made by South San Francisco, California-based biotechnology company Genentech Inc. <GNE.N>, works by blocking a gene that plays a role in tumor growth. It offers new hope for women who suffer from a rapid and often fatal form of the disease.
The drug is a so-called monoclonal antibody that homes in on a gene that is mutated in about 30 percent of women with breast cancer, causing their bodies to produce too much of a protein that "tells" cancer cells to grow.
Monoclonal antibodies, immune system cells that home in on the cancer cells, are sometimes described as "magic bullets."
"Today heralds a new era in breast cancer with a new weapon that targets an underlying genetic defect that causes cancer," Susan Hellmann, chief medical officer for Genentech, said.
The drug, also called trastuzumab, takes a new approach to fighting one type of metastatic, or spreading, breast cancer by blocking a gene, HER2 (human epidermal growth factor receptor2) that seems to promote the growth of cancer cells. By blocking its action, Herceptin seems to keep tumors from advancing.
It can be used alone or in combination with other chemotherapies, but only after women have failed with at least one other chemotherapy drug.
"Not only is (this type of cancer) more aggressive, it also can occur in somewhat younger women," said Dr. Judith Gasson, director of the Jonsson Cancer Center at the University of California, Los Angeles, which played a role in the initial research and later testing of the drug.
Herceptin is the second monoclonal antibody approved to treat cancer. The first, Genentech's Rituxan, was approved last November for patients with one type of non-Hodgkin's lymphoma, a cancer of the immune system.
Herceptin is indicated for initial treatment of patients in combination with paclitaxel -- a drug originally derived from the Pacific Yew tree -- and by itself for those who already have undergone other cancer therapy. Paclitaxel is sold under the name Taxol by Bristol-Myers Squibb Co. <BMY.N>
"Because the antibody targets the HER2 molecules ... specifically, it doesn't have the same kind of side effects as chemotherapy and radiation in terms of bone marrow suppression, hair loss, nausea and vomiting," Gasson said.
Overproduction of the HER2 protein can be determined by a test performed on a new or stored specimen of the tumor.
The HER2 gene was first linked to certain breast and ovarian cancers in 1986. Gasson said there was a possibility the drug might eventually be tested and used to combat ovarian cancers in which the HER2 protein is overproduced.
In 1992, the Herceptin antibody, combined with chemotherapy, was given to the first trial group of 15 women, all considered terminally ill. By 1996, 900 women were involved in Phase III clinical trials.
"I am happy not only to have benefited personally from Herceptin, but to know I have helped other women who also will benefit from this drug, now that it is approved," said Amy Applebaum, a breast cancer patient who was involved in the Phase III trials and is still receiving Herceptin therapy.
About 1.6 million women have been diagnosed with breast cancer in the United States, and 180,000 new cases are diagnosed in any given year, according to the American Cancer Society.
Genentech estimates there are about 164,000 women with metastatic breast cancer. Of these women, 25 percent to 30 percent have tumors that overproduce the HER2 protein and may potentially be candidates for this therapy.
The FDA said only patients who have the faulty HER2 gene will benefit from Herceptin. "When breast cancer tumors produce excess amounts of the HER2 protein, it appears that the cancer may be more aggressive," the FDA said in a statement.
The FDA cautioned, however, that patients should have their hearts checked before and closely monitored during treatment.
"We now have a new weapon in our fight against breast cancer," Health and Human Services Secretary Donna Shalala said in a statement. "For certain women with advanced disease, this new product can mean new hope."
22:57 09-25-98
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