This submission is based upon the first analysis of the combined efficacy and tolerability data from the three trials forming part of the largest international study ever conducted in prostate cancer showing that Casodex not only reduces the risk of tumour progression by almost a half, but also reduces the risk of developing bone metastases by a third. These results suggest that Casodex may be used as immediate or adjuvant treatment for early prostate cancer just as tamoxifen is used to treat breast cancer.
“Women with early stage breast cancer have been treated with the hormonal agent tamoxifen after surgery or radiation for years, no similar treatment exists for men with prostate cancer,” said Dr Gerard T. Kennealey, Vice President Oncology Research at AstraZeneca. “If this new indication for Casodex is approved, it could be another option for the thousands of patients diagnosed with early stage prostate cancer because currently there is no drug approved to treat their cancer until the disease has recurred or progressed.”
Prostate cancer affects one out of every six American men. According to the American Cancer Society, nearly 200,000 new prostate cancer cases will have been diagnosed in 2001, or about one new case every three minutes. It is the second most frequently occurring malignancy in American men, after skin cancer, and is the second leading cause of cancer death among men after lung cancer.
Casodex 150 mg for the treatment of early prostate cancer has already been approved in eleven countries*. In 2000, Casodex’s worldwide sales of $433 m showed a 31 percent increase compared to the previous year. Casodex’s growth is being fuelled by life cycle initiatives towards megabrand status within AstraZeneca’s range of products.
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Emily Denny
+44 (0)20 7304 5034
Steve Brown
+44 (0)20 7304 5033
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Jorgen Winroth
+1 609 896 4148
Mina Blair-Robinson
+44 (0)20 7304 5084
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- The countries in which Casodex (bicalutamide 150mg) has a licence for the treatment of early prostate cancer are; United Kingdom, Austria, Greece, Portugal, Italy, Belgium, Hungary, Slovakia, Czech Republic, Mexico and Luxembourg. (Source: IMS prescription data).
- The sNDA submission is based on the first analysis of the data from the Early Prostate Cancer Trial Program. The Casodex (bicalutamide 150mg) Early Prostate Cancer Programme (EPC) is the largest clinical trial programme ever in prostate cancer and comprises three prospective, double-blind placebo-controlled clinical trials conducted in 23 countries gathered in distinct geographical areas:
- Study 023: Canada and USA
- Study 024: Europe, South Africa, Australia, Israel and Mexico
- Study 025: Scandinavia
- The programme enrolled 8,113 male patients aged 38 to 93 years, with localised or locally advanced prostate cancer. The trial was set up to examine whether adding Casodex 150mg immediately to standard care (watchful waiting, radical prostatectomy or radiotherapy) can reduce the risk of disease progression and improve survival when compared to standard care alone.
- Differences in favour of bicalutamide therapy were seen across the patient population studied, irrespective of disease stage or whether patients had received prior therapy (eg radiotherapy or radical prostatectomy).’ The majority of side effects that occurred were predicted from the pharmacology of bicalutamide. As expected gynaecomastia and breast pain were the most frequent, but in the majority of patients these were mild to moderate, frequently resolving or improving when therapy was withdrawn
- Casodex interferes with the ability of cancer cells to use male hormones to grow. In the case of prostate cancer, the main hormone is testosterone (an androgen). Casodex is a nonsteroidal antiandrogen that works by blocking the action of androgens, such as testosterone, at the cellular level. Casodex 50 mg is currently the most widely prescribed nonsteroidal antiandrogen therapy for the treatment of advanced prostate cancer in the world. [i] In the USA Casodex 50 mg is approved for use in combination therapy with a luteinizing hormone-releasing hormone analog or LHRH-A (medical castration), for the treatment of Stage D2 metastatic prostate cancer. This combination therapy is referred to as Combined Androgen Blockade (CAB).
- AstraZeneca 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 $15.8 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. In the United States, AstraZeneca is an $8 billion healthcare business with more than 10,000 employees.
- AstraZeneca defines a megabrand as a product with at least $1 billion in annual sales in peak years.
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Casodex is a trademark, property of the AstraZeneca group of companies.