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FDA Approves Faslodex for Breast Cancer
Reviewed by Charlotte E. Grayson, MD
April 26, 2002 -- The FDA on Thursday approved the drug Faslodex as a secondary treatment for advanced breast cancer in postmenopausal women after antiestrogen therapy, such as tamoxifen, has failed.
Here is more about this approval:
Brand name: Faslodex
Generic name: fulvestrant for injection
Drug maker: AstraZeneca
Background: Under current guidelines, advanced breast cancer patients whose tumors depend on hormones to grow (known as hormone receptor positive tumors) are initially given drugs such as tamoxifen that block the effects of estrogen or aromatase inhibitors (such as Letrozole or Arimidex) that lessen the amount of estrogen in the body.
Faslodex is a hormonal therapy -- similar to tamoxifen -- that is designed to attack the estrogen receptors to interfere with the effects of estrogen after initial antiestrogen therapies fail.
The drug is administered by injection once a month.
Basis of this approval: The FDA based its approval on two clinical trials, one in North America and another in Europe. Researchers compared the effects of a once-monthly 250mg dose of Faslodex to a daily dose of the aromatase inhibitor Arimidex.
In the North American study, the response rate was equal at 17% for both drugs. The European study found a slight advantage for Faslodex (20% response rate vs. 15% for Arimidex).
In both studies, patients who received Faslodex had a longer time to progression of their disease than with Arimedex (5.5 months vs. 3.5 and 5.2 months).
Cautions: The most commonly reported side effects of Faslodex were nausea, vomiting, constipation, diarrhea, abdominal pain, headache, back pain, and hot flashes.
Pregnant women should not use Faslodex, because the drug may cause harm to the fetus.
Reviewed by Charlotte E. Grayson, MD
April 26, 2002 -- The FDA on Thursday approved the drug Faslodex as a secondary treatment for advanced breast cancer in postmenopausal women after antiestrogen therapy, such as tamoxifen, has failed.
Here is more about this approval:
Brand name: Faslodex
Generic name: fulvestrant for injection
Drug maker: AstraZeneca
Background: Under current guidelines, advanced breast cancer patients whose tumors depend on hormones to grow (known as hormone receptor positive tumors) are initially given drugs such as tamoxifen that block the effects of estrogen or aromatase inhibitors (such as Letrozole or Arimidex) that lessen the amount of estrogen in the body.
Faslodex is a hormonal therapy -- similar to tamoxifen -- that is designed to attack the estrogen receptors to interfere with the effects of estrogen after initial antiestrogen therapies fail.
The drug is administered by injection once a month.
Basis of this approval: The FDA based its approval on two clinical trials, one in North America and another in Europe. Researchers compared the effects of a once-monthly 250mg dose of Faslodex to a daily dose of the aromatase inhibitor Arimidex.
In the North American study, the response rate was equal at 17% for both drugs. The European study found a slight advantage for Faslodex (20% response rate vs. 15% for Arimidex).
In both studies, patients who received Faslodex had a longer time to progression of their disease than with Arimedex (5.5 months vs. 3.5 and 5.2 months).
Cautions: The most commonly reported side effects of Faslodex were nausea, vomiting, constipation, diarrhea, abdominal pain, headache, back pain, and hot flashes.
Pregnant women should not use Faslodex, because the drug may cause harm to the fetus.
