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Back to Oncology Articles
Wednesday 12th October, 2005
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The FDA has approved Pfizer's Aromasin® for adjuvant treatment of early
breast cancer in postmenopausal women.
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Pfizer Inc has received approval from the U.S. Food and Drug
Administration (FDA) to market Aromasin® (exemestane tablets) for
adjuvant treatment of postmenopausal women with estrogen-receptor
positive early breast cancer following two-to-three years of tamoxifen
for a completion of five consecutive years of adjuvant hormonal therapy.
The approval was based on the Intergroup Exemestane Study (IES) which
showed that patients who switched to Aromasin after two-to-three years
of tamoxifen, for a combined total of five years of therapy, had 31
percent more protection from cancer recurrence than those who remained
on five years of tamoxifen therapy.
This landmark study, published in the New England Journal of
Medicine, established the superiority of switching to Aromasin rather
than remaining on tamoxifen. Following its publication, the American
Society of Clinical Oncologists and the National Comprehensive Cancer
Network updated their guidelines to support the use of a new switch
regimen using Aromasin adjuvant treatment.
"Pfizer is pleased to announce this treatment advance," said Dr.
Joseph Feczko, Pfizer's chief medical officer. "This new indication for
Aromasin provides women with a new treatment regimen that can
significantly improve their chances of remaining breast cancer-free."
The IES trial involved over 4,700 postmenopausal women with
estrogen-receptor positive breast cancer who were followed for an
average of 35 months. Patients receiving Aromasin experienced a
significant reduction in the risk for recurrence of the disease,
compared to those continuing on tamoxifen. This reduction includes fewer
local and distant tumors as well as new cancers in the other breast.
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"This new approval for Aromasin clearly provides physicians and patients
a more effective way of protecting against cancer recurrence compared to
the current treatment practice of five years of tamoxifen therapy," said
Dr. Stephen Jones, medical director at U.S. Oncology Research in
Houston, Texas.
The most common side effects for Aromasin, which were
mild-to-moderate, include hot flashes (21.2%), fatigue (16.1%) and
arthalgia/ bone pain (14.6%).
Aromasin should not be administered to pre-menopausal women and women
who are pregnant. Dose modifications should be considered for patients
taking concomitant CYP3A4 inducers.
Breast cancer is one of the most common cancers occurring in women
and the second leading cause of death from cancer in women, after lung
cancer. Adjuvant therapy is treatment given following surgical removal
of a primary tumor (the first tumor that occurs before it spreads to
other parts of the body).
Last month, Pfizer received approval for adjuvant treatment in the
European Union. Aromasin was approved in the United States late in 1999
for the treatment of advanced breast cancer in postmenopausal women
whose tumors have stopped responding to tamoxifen. It also is approved
for use in Europe, Japan, and South America. Currently, Aromasin is
available in more than 50 countries around the globe.
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