AstraZeneca PLC
4 September 2000
FDA APPROVES ARIMIDEX - A NEW FIRST LINE TREATMENT OPTION FOR BREAST CANCER
AstraZeneca announced today that the U.S. Food and Drug Administration (FDA)
has approved its breast cancer treatment Arimidex as a new treatment option
for post-menopausal women first diagnosed with advanced or locally advanced
breast cancer whose cancers are hormone receptive. Arimidex is the first
aromatase inhibitor to be approved for first-line treatment in the U.S.
Previously, Arimidex was only approved for use after disease progression
following tamoxifen treatment. Two pivotal studies found that Arimidex was as
effective and well tolerated as tamoxifen when prescribed at the time of
diagnosis for women with advanced breast cancer.
Arimidex was first approved in 1996 as a treatment for post-menopausal women
with advanced breast cancer who progressed following hormonal treatment with
tamoxifen. Arimidex is a non-steroid aromatase inhibitor, which works to
lower the amount of circulating estrogens in the body. Earlier this year,
the drug gained approval in several European countries for first-line use in
post-menopausal women with advanced disease.
Arimidex and tamoxifen work in very different ways. Arimidex stops the
production of estrogen from the adrenal glands (near the kidneys) a main
source of estrogen for post-menopausal women. Tamoxifen interferes with the
cancer cell's ability to use estrogen for fuel to divide and grow. Arimidex
is also currently being evaluated in comparison to tamoxifen as an adjuvant
therapy for early breast cancer in a multinational trial called ATAC
(Arimidex, Tamoxifen And Combination therapy) with results expected in 2001.
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of ethical (prescription)
pharmaceuticals and the supply of healthcare services. It is one of the top
five pharmaceutical companies in the world with healthcare sales of US15
billion and leading positions in sales of gastrointestinal, oncology,
anesthesia including pain management, cardiovascular, central nervous system
(CNS) and respiratory products.
4 September 2000
Further enquires to:
Michael Olsson: Tel. +44 (0)20 7304 5087
Ed Seage: Tel. +1 302 886 4065
Jorgen Winroth: Tel. +1 609 896 4148
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