The Food and Drug Administration Approves the Breast Cancer Treatment Drug Tamoxifen

American Cancer Society
Thursday, 29 October 1998

The US Food and Drug Administration today (October 29, 1998) approved the breast cancer drug tamoxifen for the reduction in the incidence of breast cancer in women at high risk for developing the disease. Tamoxifen is manufactured by Zeneca Pharmaceuticals and marketed under the name Novaldex.

The FDA actions are based on results from the Breast Cancer Prevention Trial conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP) announced in April. The study concluded that women taking tamoxifen reduced their incidence of developing invasive breast cancer on average by 45 percent. Updated results released in September showed a reduction in the incidence of breast cancer in all age groups starting as early as the first year of treatment and continuing through six years of follow-up in those who began the trial in 1992.

The FDA approval of tamoxifen today is a major historic step on the road to controlling cancer," says Harmon Eyre, MD, executive vice president for research and medical affairs for the American Cancer Society. "The approval of the first widely applicable chemopreventive agent has the potential to substantially reduce the numbers of women who develop breast cancer," says Dr. Eyre. "Women who believe they are at high risk, such as women aged 35-59 who have a family history of the disease, and women over age 60, should discuss the appropriate course of action with their health care providers," says Dr. Eyre.

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