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FDA Approves New Treatment for Tamoxifen-Resistant Breast Cancer

FDA Approves New Treatment for Tamoxifen-Resistant Breast Cancer

The US Food and Drug Administration
(FDA) has granted approval to AstraZeneca’s new breast cancer drug
fulvestrant (Faslodex) for treatment of hormone-receptor-positive metastatic
breast cancer in postmenopausal women with disease progression following
antiestrogen therapy, with, for example, tamoxifen. Fulvestrant is an
estrogen-receptor antagonist without known agonist effects. It is the only
estrogen-receptor antagonist to be proven effective after tamoxifen failure.

Distinct Hormonal Therapy

Currently, advanced breast cancer patients whose tumors have
been shown to depend on hormones to grow may be given drugs such as tamoxifen
that act by blocking the estrogen receptor, or aromatase inhibitors that
decrease the amount of estrogen in a woman’s body. Fulvestrant is a hormonal
therapy that works by binding, blocking, and degrading the estrogen receptor,
and does not cause the type of side effects commonly associated with cytotoxic
chemotherapy. It is administered as a once-monthly intramuscular injection,
which may assist health-care professionals in monitoring compliance, and may
also make treatment more convenient for some patients.

"Faslodex provides an effective, new treatment option
for women with advanced breast cancer whose tumors have become resistant to
tamoxifen," said lead fulvestrant trial investigator C. Kent Osborne, MD,
Baylor College of Medicine, Houston. "When you have a new drug like
Faslodex that we can now add to that sequence of drugs, we may be able to
control the breast cancer for a longer period of time."

Gerard T. Kennealey, MD, vice president of clinical research,
oncology, for AstraZeneca, noted, "The management of advanced breast cancer
has significantly improved through sequential treatment with different hormonal
therapies. The introduction of Faslodex expands the number of options available
for sequential treatment and provides women with a new drug that works in a
different way."

Phase III Trials Confirm Activity

The FDA approval was based on data from two phase III,
randomized, multicenter studies (one in North America and one predominantly in
Europe) comparing fulvestrant, 250 mg once monthly injection, to daily 1-mg oral
anastrozole (Arimidex) tablets. The total of 851 women enrolled in both trials
were postmenopausal with a variety of involved sites (including liver and lung)
and had been treated with one prior hormonal therapy—in almost all cases,


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