Nolvadex Approved to Reduce Risk in Patients With DCIS

WILMINGTON, Del—AstraZen-eca announced in a news release that the FDA has approved Nolvadex (tamoxifen) to reduce the risk of invasive breast cancer in women with ductal carcinoma in situ (DCIS) following breast surgery and radiation. Nolvadex is the first medication to be approved for DCIS, which accounts for nearly 20% of all newly diagnosed breast cancers, the company said.

“The approval of tamoxifen to reduce the risk of invasive breast cancer in women with DCIS is an important advance in the management of breast cancer,” said Monica Morrow, MD, director, Lynn Sage Breast Center, Northwestern University Medical School.

Said Jerry P. Lewis, MD, senior director, clinical research oncology, Astra-Zeneca, “The effectiveness of Nolvadex has now been proven across all stages of the breast cancer continuum from risk reduction in women at high risk to the treatment of advanced breast cancer.”

AstraZeneca filed a supplemental new drug application (NDA) with the FDA for the DCIS indication in December 1999 and was granted priority review in March 2000.

The FDA submission was based on data from a study conducted by the NSABP and published in The Lancet that included 1,804 women with DCIS who had a lumpectomy and radiotherapy.

Half of those patients were prescribed Nolvadex and half received a placebo. After an average follow-up of more than 5 years, the researchers found that the addition of Nolvadex to the treatment regimen significantly reduced the incidence of invasive breast cancer by 43%, compared with placebo (P = .004). Survival was similar in the placebo and Nolvadex groups.