Here's more detail on fareston:
Fareston Now Available As First-Line Treatment Of
Metastatic Breast Cancer
MADISON, NJ -- December 3, 1997 -- Schering-Plough Corp. today announced
Fareston(R) (toremifene citrate) 60 mg Tablets is now available nationwide as a
first-line treatment for metastatic breast cancer in postmenopausal women with estrogen
receptor positive or unknown tumours -- estimated to affect more than 135,000
American women in 1997.
Fareston, the first new antiestrogen treatment for breast cancer to become available in
the United States in 19 years, received marketing clearance from the U.S. Food and
Drug Administration in May.
The drug is a once-daily oral antiestrogen that reduces breast tumour size by binding to
estrogen receptors on breast cancer cells, thereby blocking estrogen from further
stimulating tumour growth. Schering-Plough has marketing rights to Fareston in the U.S.
and Canada as well as in certain other countries through an exclusive agreement with
Orion Corp. of Finland.
Breast cancer is the most common form of cancer in women in the U.S. and is the
leading cause of cancer death for U.S. women between the ages of 40 and 55. It is
estimated that some 44,000 U.S. women will die from the disease in 1997, according
to the National Cancer Institute.
Fareston is indicated for first-line use in the treatment of metastatic breast cancer in
postmenopausal women with estrogen receptor positive or unknown tumours. It is
contraindicated in patients with known hypersensitivity to the drug.
The chemical structure of Fareston differs from that of tamoxifen, a widely-used
antiestrogen, by the substitution of a chlorine atom for a hydrogen atom in the 4-position
of the ethyl prosthetic group of the molecule. The chlorine atom may prevent the
generation of reactive metabolites that bind DNA and are characteristic of tamoxifen
metabolism. (The clinical significance of these data has not been demonstrated.)
A New Drug Application (NDA) for Fareston was filed in December 1994 by Orion
Pharma. Support for the NDA included data from three clinical trials involving a total of
1,526 patients who had no prior therapy for advanced breast cancer and were estrogen
receptor positive or receptor unknown. These trials demonstrated that Fareston is a
safe and effective alternative to tamoxifen as a first-line treatment of metastatic breast
cancer in postmenopausal patients.
The most frequently reported side effects associated with the drug include hot flashes,
sweating, nausea and vaginal discharge. These adverse reactions typically occur at the
beginning of treatment. During the three trials, only about one percent of the patients
receiving Fareston 60 mg discontinued treatment as a result of adverse effects. As with
other antiestrogens, tumour flare, hypercalcemia and vaginal bleeding have been
reported in some breast cancer patients.
The drug is currently available in several countries for the treatment of advanced breast
cancer. In February 1996, the European Union's (EU) Commission of the European
Communities granted marketing authorization to Fareston as a first-line treatment of
hormone-dependent metastatic breast cancer in postmenopausal women. The
marketing authorization is valid in all 15 EU-member states.
More information on: Fareston, Schering-Plough Corp. |
