The US Food and Drug Administration (FDA)
has granted a 6-month priority review status to the supplemental new drug
application filed by the AstraZeneca corporation for the use of anastrozole
(Arimidex) in the adjuvant treatment of early breast cancer in postmenopausal
women. Priority review status is granted for new drugs or indications that
represent a significant improvement in efficacy or safety over existing
"AstraZeneca is committed to constantly expanding the
treatment options breast cancer patients have at their disposal to fight this
disease," said Gerard T. Kennealey, MD, vice president of clinical
research, oncology, for AstraZeneca. "The FDA’s granting of priority
review status for Arimidex as an early breast cancer treatment is an important
milestone in the history of breast cancer treatment."
Priority review status for anastrozole was based on data from
the ATAC study (Arimidex and Tamoxifen, Alone or in Combination) conducted in
more than 9,300 postmenopausal women with early breast cancer. Early results
from that study showed that anastrozole reduced the risk of disease recurrence
by 17% over tamoxifen as well as the risk of contralateral breast cancer by 58%
Anastrozole is currently approved for first-line treatment of
postmenopausal women with hormone receptor-positive or hormone receptor-unknown
locally advanced or metastatic breast cancer and also for the treatment of
advanced breast cancer in postmenopausal women with disease progression
following tamoxifen therapy. Common side effects seen in clinical trials have
included hot flashes, nausea, asthenia, back and bone pain, and increased cough.
Joint pain and stiffness have also been reported.