Aromasin Now the First and Only Hormonal Breast Cancer Drug Approved for
Switch Regimen Following Initial Adjuvant Tamoxifen Therapy
NEW YORK, Sept. 13 /PRNewswire-FirstCall/ -- Pfizer Inc said today that it
has received European Mutual Recognition Procedure (MRP) approval to market
Aromasin(R) (exemestane tablets) for a new indication, adjuvant treatment of
estrogen receptor positive invasive early breast cancer following two-to-three
years of initial adjuvant tamoxifen therapy in postmenopausal women.
Aromasin is a hormonal therapy, used to treat women with breast cancers
that depend on a hormone, specifically estrogen, for growth and survival. An
estimated two-thirds of breast cancer cases are estrogen-dependent.
The approval was based on the Intergroup Exemestane Study (IES) that
showed patients who switched to Aromasin after two to three years of tamoxifen
had a 31 percent better probability of disease-free survival than those who
remained on tamoxifen.
"All patients deserve to have the greatest possibility of living disease
free. For too long, patients with breast cancer have simply been given
tamoxifen for five years hoping that it works. Patients now have an extra
option -- at no increased risk in terms of side effects," said Prof. R.
Charles Coombes, Imperial College, Hammersmith Hospital, London and lead
investigator of the IES study. "They can simply switch after two-to-three
years of taking tamoxifen to exemestane."
Data from the IES study supporting the new indication for Aromasin was
published in the New England Journal of Medicine in March 2004. The 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, as compared to those continuing on tamoxifen. This
reduction includes fewer local and distant tumors as well as new cancer in the
other breast.
In the IES study, treatment with Aromasin was associated with fewer of the
potentially serious side effects commonly associated with tamoxifen, including
a significant reduction in thromboembolic events. Additionally, Aromasin had
no significant impact on bone fracture rate.
Aromasin is well tolerated and the side effects associated with the
treatment are generally mild to moderate. Aromasin should not be administered
to pre-menopausal women and women who are pregnant. Dose modifications should
be considered for patients taking concomitant potent CYP3A4 inducers. In
patients with early breast cancer the most commonly reported adverse reactions
were hot flushes (22%), arthralgia (17%) and fatigue (17%). In patients with
advanced breast cancer the most commonly reported adverse reactions were hot
flushes (14%) and nausea (12%).
Breast cancer is the most common cancer occurring in women (excluding
cancers of the skin) and the second leading cause of death from cancer in
women, after lung cancer. Each year, an estimated 200,000 women in the
European Union are diagnosed with breast cancer and approximately 80,000 women
die of the disease. Adjuvant therapy is treatment given following surgical
removal of a primary tumour (the first tumour that occurs before it spreads to
other parts of the body).
The UK acted as the Reference Member State for the European Mutual
Recognition Variation Procedure, which covers 15 other countries.
Subsequently, the UK national approval was granted, and similar national
approvals in the rest of the MRP countries of the new early breast cancer
indication are expected in the near future. Aromasin has also been newly
approved for use in early breast cancer in Switzerland and New Zealand.
In 1999, Aromasin was approved in Europe through Mutual Recognition
Procedure for treatment of advanced breast cancer after prior anti-estrogen
therapy. The U.S. Food and Drug Administration approved Aromasin for advanced
breast cancer in post menopausal women whose disease has progressed following
tamoxifen therapy in late 1999. Currently, Aromasin is available in more than
50 countries around the globe.
SOURCE Pfizer Inc
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