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AstraZeneca Receives FDA Approval for Faslodex (fulvestrant): A New Type of Breast Cancer Treatment Effective In Tamoxifen-Resistant Breast Cancer

Wilmington, Del.—April, 25, 2002 — The U.S. Food and Drug Administration (FDA) has granted approval to AstraZeneca (NYSE:AZN) for their new breast cancer drug Faslodex (fulvestrant) Injection for treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy, such as tamoxifen. Faslodex is an estrogen receptor antagonist without known agonist effects. It is the only estrogen receptor antagonist to be proven effective after tamoxifen failure.

Currently, advanced breast cancer patients whose tumors have been shown to depend on hormones to grow, may be given drugs like tamoxifen that act by blocking the estrogen receptor, or aromatase inhibitors that lessen the amount of estrogen in a woman's body. Faslodex 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 Faslodex trial investigator C. Kent Osborne, M.D., Baylor College of Medicine, Houston, Texas. "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."

"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," said Gerard T. Kennealey, M.D., Vice President of Clinical Research, Oncology, for AstraZeneca.

The FDA approval was based on data from two Phase III, randomized, multi-center studies (one in North America and one predominantly in Europe) comparing Faslodex 250mg once monthly injection to daily 1mg oral ARIMIDEX® (anastrozole) tablets, the most commonly prescribed aromatase inhibitor. The women in the trials (851 patients total) 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 tamoxifen. The effectiveness of Faslodex was established by comparison to the selective aromatase inhibitor ARIMIDEX as measured by objective response rate and time to progression (TTP). Objective response rate in the North American trial was 17% with Faslodex vs 17% with ARIMIDEX, and in the European trial 20% with Faslodex vs 15% with ARIMIDEX. The reported TTP for Faslodex vs ARIMIDEX was 5.5 months vs 3.5 months in the North American trial, and 5.5 months vs 5.2 months in the European trial.

Faslodex can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised not to become pregnant while receiving Faslodex.

The most commonly reported adverse events seen with Faslodex vs. anastrozole treatment, regardless of the investigator's assessment of causality, were gastrointestinal symptoms (nausea 26.0% vs. 25.3%, vomiting 13.0% vs. 11.8%, constipation 12.5% vs. 10.6%, diarrhea 12.3% vs. 12.8%, abdominal pain 11.8% vs. 11.6%), headache (15.4% vs. 16.8%), back pain (14.4% vs. 13.2%), hot flushes (17.7% vs. 17.3%), and pharyngitis (16.1% vs. 11.6%). Injection site reactions with mild, transient pain and inflammation were reported in 7% of patients (1% of treatments) given single 5 mL and 27% of patients (4.6% of treatments) given 2 x 2.5 mL injections of Faslodex.

AstraZeneca (NYSE:AZN) is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $16.4 billion and leading positions in sales of gastrointestinal, oncology, anesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. In the United States, AstraZeneca is an $8.7 billion healthcare business with more than 10,000 employees.
For more information about AstraZeneca please visit www.astrazeneca-us.com

Source: AstraZeneca

Posted: April 2002

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