In April 2002, the FDA approved Faslodex (fulvestrant) for the treatment of hormone receptor positive metastatic breast cancer in postmenopausal women whose disease progresses following anti-estrogen therapy.
In this type of breast cancer, estrogen can stimulate the growth of tumors by entering cells at multiple sites called estrogen receptors. Faslodex inhibits this action of estrogen and appears to reduce the number of estrogen receptors in breast cancer cells.
Faslodex was found to be as effective as the drug anastrozole in two randomized, controlled clinical trials in postmenopausal women with locally advanced or metastatic breast cancer that progressed following treatment with tamoxifen. Anastrozole is another drug used to decrease estrogen production and suppress the growth of tumors that need estrogen to grow. Faslodex is administered as a monthly injection into the buttocks.
The most commonly reported side effects were nausea, headache, back pain, vomiting, constipation, diarrhea, abdominal pain, hot flushes, and pharyngitis (inflammation of the throat), regardless of whether patients were treated with Faslodex injections or anastrozole tablets. Pain at the site of the injection was reported in about 10 percent of patients treated with Faslodex.
Faslodex is indicated for postmenopausal women and should not be given to pregnant women because of the risk of harm to a fetus.
Faslodex is distributed in the United States by AstraZeneca Pharmaceuticals LP, Wilmington, Del.
COPYRIGHT 2002 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group