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| |  European Committee Gives Positive Opinion on Approvability for Breast Cancer Therapy Faslodex (Fulvestrant) The First Oestrogen Receptor Antagonist With No Agonist Effects On Track to Offer New Hope for Women in Europe With Advanced Postmenopausal Breast Cancer LONDON, ENGLAND -- November 21, 2003 -- AstraZeneca announced today that it has received a positive 'Opinion' on the approvability of its breast cancer therapy 'Faslodex' (fulvestrant). The CPMP recommended 'Faslodex' for marketing approval in the EU in a statement posted on the European Agency for the Evaluation of Medicinal Products (EMEA) website today. CPMP, the scientific advisory body to the European Commission made up of scientific experts from the EU member states, 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'. Following submission of a Marketing Authorisation Application (MAA) to the EMEA in February earlier this year, the CPMP 'Opinion' marks a positive step on the road to approval in Europe for 'Faslodex. 'Faslodex' is a new type of endocrine therapy; an oestrogen receptor antagonist with no agonist (oestrogen-like) effects that downregulates the oestrogen receptor. 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 anti-oestrogen 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. On the announcement today, Brent Vose, Vice-President of Oncology, AstraZeneca commented, "'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." Tony Howell, Professor of Medical Oncology, Christie Hospital, Manchester further commented 'this positive opinion given for marketing approval in the EU is exciting to physicians as 'Faslodex' offers an additional treatment option with a different mechanism of action to any other currently available endocrine therapy. This is extremely good news for postmenopausal women with advanced breast cancer.' This is the first time AstraZeneca has submitted a MAA (Marketing Authorisation Application) 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 Marketing Authorisation for 'Faslodex' in Europe was based on data from two pivotal phase III trials,1,2 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. · Breast cancer is the most common cancer among women in most European countries.4 Given current patterns of occurrence by age, about one in 12 women will develop the disease before the age of 75.4 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.5 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 antiestrogen 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). · References:
SOURCE: AstraZeneca
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