Home  Media Press releases 2003
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| 21 November 2003 | 2003-11-21T00:00:00.0000000-00:00 |
| POSITIVE OPINION GIVEN ON APPROVABILITY OF FASLODEX™ (FULVESTRANT) IN EUROPEAN UNION (EU)
AstraZeneca announced today that it has received a positive opinion on EU marketing approval of its breast cancer therapy Faslodex™ (fulvestrant) from the Committee for Proprietary Medicinal Products (CPMP), scientific advisory body to the European Commission. The CPMP concluded that, on the basis of the quality of safety and efficacy data submitted, ‘there is a favourable risk balance for Faslodex and therefore recommends the granting of the marketing authorisation.’ | This CPMP recommendation, posted today on the European Agency for the Evaluation of Medicinal Products (EMEA) website, marks a positive step towards European approval for Faslodex. It is the first time AstraZeneca has submitted a Marketing Authorisation Application MAA) via the European Centralised Procedure, which will result in a single licence throughout the EU, Norway and Iceland, and additional countries when the number of EU member states expands in May 2004. Following formal EU approval, which is anticipated early next year, AstraZeneca expects first launches of Faslodex in Europe in the second quarter, 2004. Faslodex is currently commercially available in the US and Brazil.
The CPMP recommended Faslodex for “the treatment of postmenopausal women with oestrogen receptor positive locally advanced or metastatic breast cancer for disease relapse on or after adjuvant antioestrogen therapy or disease progression on therapy with an anti-oestrogen.” As Faslodex has been shown to be effective after the disease has recurred or progressed on anti-oestrogen therapy such as tamoxifen, the drug may help extend the window of opportunity for women to be treated with endocrine therapy. Faslodex is a new type of endocrine therapy; an oestrogen receptor antagonist with no agonist (oestrogen-like) effects that downregulates the oestrogen receptor. Since its launch in the US in 2002, Faslodex sales have increased by 189 per cent during the first nine months of 2003, to over $55 million. The endocrine breast cancer market in Europe is currently worth over $300 million.
Brent Vose, Vice-President of Oncology, AstraZeneca said, “Faslodex is a new and effective endocrine treatment which will provide greater choice for postmenopausal women with hormone-sensitive advanced breast cancer. We are delighted that the CPMP opinion posted today brings us one step closer to offering a new hope for the thousands of women in Europe with this serious disease.”
The European submission for Faslodex is based on data from two pivotal phase III trials, which compared the efficacy and tolerability of Faslodex to that of Arimidex (anastrozole) in the treatment of hormone sensitive advanced breast cancer in postmenopausal women who had previously been treated with prior endocrine therapy.
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Notes to Editor:
Breast cancer is the most common cancer among women in most European countries. Given current patterns of occurrence by age, about one in 12 women will develop the disease before the age of 75. There are approximately 345,000 new cases of breast cancer in Europe each year and an estimated 130,000 women per year will die of this devastating disease. These statistics reinforce the necessity for new, effective treatment options to help combat this disease.
Faslodex is administered as a once a month intramuscular injection, which may offer compliance benefits and since it is an endocrine treatment, it does not cause the side effects commonly associated with chemotherapy. ·
Faslodex works differently to other antioestrogen agents for breast cancer, in that it binds to the oestrogen receptor in the breast cancer cell, and this interaction results in loss of the cellular oestrogen receptor (down-regulation). Faslodex attacks cancer cells that have grown resistant to current antioestrogen treatment options.
Advanced breast cancer is diagnosed when the tumour has spread to the underlying tissues of the chest wall (locally advanced disease) or when the cancer has spread to sites/other organs beyond the breast (metastatic disease).
AstraZeneca continues its tradition of research excellence and innovation in oncology that led to the development of its current anti-cancer therapies including Arimidex, Casodex, Faslodex, Nolvadex, Tomudex and Zoladex as well as a range of novel targeted products such as anti-proliferatives, anti-angiogenics, vascular targeting and anti-invasive agents. AstraZeneca is also harnessing rational drug design technologies to develop new compounds that offer advantages over current cytotoxic and hormonal treatment options. The company has over 20 different anti-cancer projects in research and development.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of 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 $17.8 billion and leading positions in sales of oncology, gastrointestinal, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products.
Faslodex, Arimidex, Casodex Nolvadex, Tomudex and Zoladex are trademarks of the AstraZeneca group of companies
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