WILMINGTON, DelAstraZen-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.