NOLVADEX BREAST CANCER :

The United States Food and Drug Administration’s oncologic drugs advisory committee has recommended for approval Zeneca Pharmaceuticals’ Nolvadex(R) (tamoxifen citrate) for reduction of the incidence of breast cancer in women at increased risk, as defined by the National Cancer Institute/National Surgical Adjuvant Breast and Bowel Project's Breast Cancer Prevention Trial population.

Nolvadex is currently the most widely prescribed therapy for early and advanced breast cancer. More than 10 million patient years of experience with Nolvadex treatment since its first introduction in 1973 have demonstrated that this medication significantly prolongs overall patient survival. Nolvadex is the only hormonal therapy indicated for the treatment on early and advanced breast cancer.

It is believed that Nolvadex acts by primarily competing with the female hormone, estrogen, for estrogen receptors in the nuclei of some breast cancer cells. By binding to these receptors and blocking the stimulatory effects of estrogen, Nolvadex inhibits the growth and metabolism of breast cancer cells.

Adverse reactions to Nolvadex are relatively mild and rarely severe enough to require discontinuation of treatment. The most frequently reported adverse reactions are hot flashes, vaginal discharge and irregular menses. Deep vein thrombosis and pulmonary embolism, although uncommon, occur more frequently with Nolvadex than placebo.

As previously known, an increased risk of changes in the endometrium (lining of the uterus), including endometrial cancer, has been associated with Nolvadex treatment. Healthy women in the general population have reported endometrial cancer of 0.7 cases per 1,000 women. Women with breast cancer, regardless of any treatment they may receive, have an increased risk of endometrial cancer: about one case per 1,000 women. Among breast cancer patients treated with Nolvadex, between two and three cases per 1,000 women per year may be diagnosed.

Breast cancer is the most common form of cancer in women in the U.S. with one out of nine women developing the disease in her lifetime. In 1998, 178,700 new cases will be diagnosed and 43,500 women will die from the disease.