HHS NEWS

U.S. Department of Health and Human Services 

P98-34                         FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE          Print Media:         301-827-6242
October 29, 1998               
                               Consumer Inquiries:  800-532-4440

TAMOXIFEN APPROVED FOR REDUCING BREAST CANCER INCIDENCE

The Food and Drug Administration today announced the approval of Nolvadex (tamoxifen citrate), for reducing the incidence of breast cancer in women at high risk for developing the disease. This new indication for tamoxifen, which has been used as a breast cancer treatment for more than 20 years, resulted from a recent study of the drug, conducted by the National Cancer Institute (NCI), in women who were judged to be at increased risk of breast cancer. The study showed that tamoxifen reduced the chance of getting breast cancer by 44 percent. The data also showed that tamoxifen treatment did not completely eliminate breast cancer risk, and that its longer term effects are not known.

"Breast cancer is the second leading cause of cancer death in American women and accounts for 31 percent of all cancers among women. Today's action provides an important new option for some women at heightened risk of breast cancer." said HHS Secretary Donna E. Shalala.

In approving the drug for this new indication, FDA emphasizes that Nolvadex should be prescribed only for women at high risk for breast cancer following a medical evaluation of a woman's individual risk factors including age, personal health history and family history of breast cancer -- factors outlined in the approved labeling.

The agency notes that caution must be used in prescribing the drug because of its potentially serious side effects including endometrial cancer (cancer of the lining of the uterus), deep vein thrombosis (blood clots in major veins), and pulmonary embolism (serious blood clots in the lungs).

"As with all drugs, there are risks associated with use. As valuable as tamoxifen is to some patients, FDA strongly advises women and their doctors to carefully weigh the benefits and risks of tamoxifen before patients use the drug," said Dr. Michael A. Friedman, Acting FDA Commissioner.

The NCI study used a computerized model, called the "Gail model", for assessing a woman's risk of breast cancer. Recognizing that not all health care providers have access to this computer model, the manufacturer will provide materials to calculate risk. The FDA has also required that labeling provide information for doctors to help them identify women who should receive the drug:

For example, the labeling specifies that for women age 50 or older, the following risk factors would result in an increased risk of breast cancer:

Today's approval of the new indication for tamoxifen was based on the NCI study of more than 13,000 patients which was conducted by one of NCI's national clinical trials networks called the National Surgical Adjuvant Breast and Bowel Project (NSABP). The trial was halted 14 months early, in March l998, when interim results showed that tamoxifen reduced breast cancer incidence by almost one half.

FDA's decision is in keeping with the FDA's Oncologic Drugs Advisory Committee recommendation, in September 1998, that tamoxifen be approved for high risk women for the reduction in the incidence of breast cancer. FDA will also require that adequate patient follow-up to determine the extent of the benefits and risks of long term use and emphasized that physicians and patients should be given educational information about the drug's potential benefits and risks.

The manufacturer, Zeneca Pharmaceutical, Inc. of Wilmington, Del., submitted a supplemental new drug application for tamoxifen's new use on April 30 and at that time, FDA committed to a six-month review.

For more information on tamoxifen, go to www.fda.gov/cder/news/tamoxifen/ on the Center for Drug Evaluation and Research website.

ATTENTION TV BROADCASTERS: Please use open caption for the hearing impaired.
[FDA HOME PAGE]