ASTRAZENECA SUBMITS SUPPLEMENTAL NEW DRUG APPLICATION TO FDA FOR CASODEX 150 MG FOR THE TREATMENT OF EARLY STAGE PROSTATE CANCER

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Note to News Editors:

• 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but in the majority of patients these were mild to moderate, frequently resolving or improving when therapy was withdrawn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.