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Fulvestrant (AstraZeneca).
1Department of Medicine, Royal Marsden Hospital and Institute of Cancer Research, London, UK. stephen@icr.ac.uk
Current Opinion in Investigational Drugs (London, England : 2000)
|May 22, 2002
Summary
Fulvestrant (Faslodex) is an estrogen receptor downregulator for breast cancer treatment. AstraZeneca filed an NDA in 2001, anticipating a 2002 US launch, with potential for other estrogen-responsive tumors.
Area of Science:
- Oncology
- Pharmacology
Background:
- Fulvestrant (Faslodex) is an investigational estrogen receptor (ER) downregulator developed by AstraZeneca.
- It is being developed for the potential treatment of breast cancer and other estrogen-responsive tumors.
Purpose of the Study:
- To summarize the development status and market expectations for Fulvestrant.
- To highlight its potential in treating advanced breast cancer and other estrogen-dependent conditions.
Main Methods:
- Review of regulatory filings and clinical trial status.
- Analysis of market forecasts and sales projections from financial institutions.
Main Results:
- A New Drug Application (NDA) was filed in the US in March 2001 for second-line advanced breast cancer treatment.
- Late-stage trials were ongoing in Japan for breast cancer in August 2001.
- Phase II trials for uterine fibroids and endometriosis were previously reported but showed no subsequent development.
Conclusions:
- Fulvestrant was anticipated to launch in the US in early 2002.
- Significant market potential was projected, with sales expected to reach $800 million in peak year.
- Development for non-breast cancer indications appears to have stalled.