Answers
06/25/1990

<TITLE>Breast Cancer Drug Aprroval</TITLE>
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                         BREAST CANCER DRUG APPROVAL
    The FDA has approved the use of tamoxifen citrate, a hormone-blocking 
agent approved and widely used in the treatment of metastatic breast cancer,
for a major additional use to help prevent the recurrence of cancer in
"node-negative" patients. A node-negative patient is one in whom the
cancerous cells have not spread from the breast area to the lymph nodes 
under the arm.
    The following may be used to answer questions.
    Since its original approval in 1977 for patients with advanced breast 
cancer, tamoxifen has gradually been tested and found to be effective in
several additional breast cancer patient populations. 
    It is thought that tamoxifen works by blocking the effects of the 
hormone estrogen on tumor growth.  In node negative patients the drug is
indicated for use following lumpectomy or modified radical mastectomy.
    Breast cancer strikes one out of every ten American women. Over 44,000
women will die from the disease this year alone, making it the second 
largest cause of female death from cancer.
    Tamoxifen citrate is sold under the trade name Nolvadex by ICI
Pharmaceuticals of Wilmington, Delaware.
    FDA's Oncologic Drugs Advisory Committee on June 29 will discuss a
protocol to study tamoxifen citrate for use in breast cancer prevention in
healthy postmenopausal women. 
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