AstraZeneca expects to file a new drug application with the US Food and Drug Administration (FDA) and European regulatory authorities for ICI182780 (Faslodex®) early next year.
Breast cancer is associated with industrialisation, a western diet and aging population, with about 750,000 new cases diagnosed annually, and about one-in-10 women diagnosed with the disease. The breast cancer market represents treatment sales of more than $2bn. A significant minority of sufferers are diagnosed with recurrent or advanced breast cancer, with half dying within three years of diagnosis.
ICI182780 (Faslodex®) is an Estrogen Receptor Downregulator, and when approved will represent the first in a new class of breast cancer treatments. It accelerates receptor degradation and blocks estrogen-stimulated tumour growth, unlike currently available hormonal treatments that act by inhibiting the activity of the estrogen receptor or by reducing the amount of estrogen in a woman's body.
Currently, advanced breast cancer patients whose tumours have been shown to use hormones to grow, are usually placed on Nolvadex® or Arimidex® until their tumours no longer respond to that treatment. After a period of time, most tumours become resistant to these types of treatments and cancer will progress. Through ICI182780's (Faslodex's®) novel targeting and destruction of the estrogen receptor, it may provide another way to attack the cancer cell, thus providing physicians a new tool to combat the disease, without adding the toxic side effects often experienced with chemotherapy.
Two phase III, randomised, multi-center studies compared ICI 182780 (Faslodex®) 250 mg once monthly injection vs. daily 1mg oral Arimidex®. Both studies were in postmenopausal women with advanced breast cancer (851 patients total) who had progressed or recurred on prior endocrine therapy. For the endpoints of time to progression, objective response, clinical benefit rate, and duration of response, the trends were all in favour of ICI182780 (Faslodex®). Moreover, the median duration of response in the blinded North American Trial (0021) was 19.3 months with ICI182780 (Faslodex®) compared with 10.5 months with Arimidex®.
A multinational Phase III clinical trial comparing ICI182780 (Faslodex®) with tamoxifen in advanced breast cancer has completed recruitment and results are expected during 2001.
AstraZeneca continues its tradition of research excellence and innovation in Oncology that led to the development of its current anti-cancer therapies including Nolvadex®, Zoladex®, and Arimidex®. AstraZeneca has some promising new oncology therapies including ZD 1839 ('Iressa'), an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TK) currently in clinical trials research for different tumour types.
Further information is also available at BrCaWatch.com, or access the world wide web at www.astrazeneca.com.
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Steve Brown
+44 (0)20 7304 5033
Lucy Williams
+44 (0)20 7304 5034
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- Thousands of women are diagnosed with advanced breast cancer each year. With the variety of treatment options available today, more women with advanced breast cancer are living longer with the disease. Advanced breast cancer is diagnosed when cancer that is originally confined to the breast is found in other parts of the body. More specifically, a woman is considered to have advanced disease when breast cancer cells form a tumour in places such as the lungs, liver or bones. Locally advanced disease is when the cancer has spread to the lymph nodes, but is not present elsewhere in the body.
- Arimidex® is currently approved for the first-line treatment of advanced breast cancer in postmenopausal women in 27 markets - the US, UK, Italy, France, Germany, Canada, Spain, Austria, Belgium, Brazil, Denmark, Finland, Ireland, Luxembourg, Mexico, Netherlands, New Zealand, S. Africa, Slovakia, Czech Republic, Malta, Norway, Australia, Switzerland, Portugal, Argentina and Singapore.
- Arimidex® is also available in most countries for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following treatment with tamoxifen or other anti-oestrogens.
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