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First Breast Cancer Prevention Drug Given Clearance by FDA; Fox Chase Doctors Applaud the Approval

PHILADELPHIA (November 4, 1998) -- The Food and Drug Administration 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) at hospitals across the country including Fox Chase Cancer Center in Philadelphia.

Mary Daly, M.D. at Fox Chase was a principal investigator in the breast cancer prevention trial. The study was conducted on women who were judged to be at increased risk of the disease.

"The trial showed that tamoxifen reduced the chance of getting breast cancer by 44 percent. Because of those results, the study was halted early and women who had been taking the placebo were given the option of taking tamoxifen," Daly said.

At Fox Chase, Dr. Daly is the director of the Margaret Dyson Family Risk Assessment Program. It is designed to help healthy women identify their risk of getting breast cancer based on their family history.

"The approval of tamoxifen will benefit thousands of women," said Daly. "Fox Chase Cancer Center's Family Risk Assessment Program is key to identifying women at high-risk, but until now, we haven't had a preventative way to help these women. Tamoxifen will give them one option in taking control of their health."

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. Those factors include age, personal health history and family history of breast cancer--factors outlined in the approved labeling.

Breast cancer is the second leading cause of cancer death in American women and accounts for 31 percent of all cancers among women. Thursday'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 data also showed that tamoxifen treatment did not completely eliminate breast cancer risk and that its long-term effects are not known.

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).

"It's important to weigh the benefits and risks of tamoxifen before prescribing the drug," cautioned Daly. "We recommend that women consult a doctor who is fully informed about tamoxifen." The FDA requires adequate patient follow-up to determine the extent of the benefits and risks of long term use.

Fox Chase Cancer Center is a selected site for a new breast cancer prevention trial (STAR, Study of Tamoxifen and Raloxifene) comparing tamoxifen and raloxifene. Raloxifene, already approved by the FDA for reducing bone loss, appears to have similar benefits as tamoxifen, but it may not have the same side effects. The trial is expected to begin after the first of the year. For more information on STAR call the Cancer Information Service at 1-800-4-CANCER.

Fox Chase Cancer Center is one of 34 National Cancer Institute-designated comprehensive cancer centers in the nation. The Center's activities include basic and clinical research, prevention, detection and treatment of cancer and community outreach programs.

Fox Chase Cancer Center, part of the Temple University Health System, is one of the leading cancer research and treatment centers in the United States. Founded in 1904 in Philadelphia as one of the nation’s first cancer hospitals, Fox Chase was also among the first institutions to be designated a National Cancer Institute Comprehensive Cancer Center in 1974. Fox Chase researchers have won the highest awards in their fields, including two Nobel Prizes. Fox Chase physicians are also routinely recognized in national rankings, and the Center’s nursing program has received the Magnet recognition for excellence four consecutive times. Today, Fox Chase conducts a broad array of nationally competitive basic, translational, and clinical research, with special programs in cancer prevention, detection, survivorship, and community outreach.  For more information, call 1-888-FOX CHASE or (1-888-369-2427).

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