Nolvadex approved for breast cancer use

Drug Store News, Nov 23, 1998 by Ellen R.Ph. Kim

The Food and Drug Administration has approved Zeneca's breast cancer drug Nolvadex (tamoxifen citrate) for the reduction of breast cancer incidences in women at high risk for developing the disease. The new indication makes Nolvadex the first and only drug to be approved for this indication. The FDA has also approved the drug for a second new indication, reduction of contraleteral breast cancer incidences. Current data from clinical trials were also added that support five years of adjuvant Nolvadex therapy for patients with breast cancer.

The FDA's actions are based on results from the Breast Cancer Prevention Trial, sponsored by the National Cancer Institute, which concluded that women taking Nolvadex reduced their incidence of developing invasive breast cancer on average by 44 percent. Updated results published in September concluded the incidence of invasive breast cancer was reduced by 51 percent in women aged 50-59 and 55 percent for women age 60 and older.