The US Food and Drug Administration (FDA) has approved AstraZeneca's breast cancer treatment Arimidex® (anastrozole) as a new treatment option for postmenopausal 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.
"It's important for patients to have the option to receive
Arimidex therapy when they are first diagnosed with advanced breast
cancer," said Gershon Locker, M.D., medical oncologist at
Evanston-Northwestern Healthcare. "Arimidex has been shown to be as
effective as tamoxifen is in women with advanced disease and study
data suggest Arimidex may lessen the rate of disease progression."
The North American trial 030 showed Arimidex had a statistically
significant advantage over tamoxifen for time to tumor progression
with an average of 11.1 months for Arimidex versus 5.6 months for
tamoxifen. The complete and partial tumor response rates were not
different between the two groups. The European trial 027 showed
Arimidex was as effective as tamoxifen with respect to both time to
progression and tumor response rate. Patients with estrogen receptor
positive breast cancer received the greatest benefit from Arimidex.
At least 10,500 women are diagnosed with advanced breast cancer
each year. With the variety of treatment options available today, more
women with advanced breast cancer are living longer with the disease.
Advanced breast cancer is diagnosed when cancer that is originally
confined to the breast is found in other parts of the body. More
specifically, a woman is considered to have advanced disease when
breast cancer cells form a tumor in places such as the lungs, liver or
Arimidex was first approved in 1996 as a treatment for
postmenopausal 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. 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
Arimidex is indicated for the treatment of advanced breast cancer
in post-menopausal women with hormone receptor positive or hormone
receptor unknown disease. Patients must exclude pregnancy before
taking Arimidex as it may cause fetal harm when administered to a
pregnant woman. Side effects including, nausea, headache and hot
flashes have been reported during treatment with Arimidex. Arimidex is
administered orally, once daily as 1-mg tablets.
For full prescribing information on Arimidex, call Mary Lynn
Carver at 302-886-7859.