The UK is acting as the reference member state in a European Union recognition procedure and, within that procedure, approval for the new indication was also granted in Greece, Portugal and Austria. Licences in other European markets are anticipated.
These approvals are based on results from the worlds largest prostate cancer treatment trial that found that Casodex™ 150mg can significantly reduce (by 42 percent) the risk of the disease progressing in patients with early prostate cancer, when taken in addition to standard therapy (watchful waiting, radical prostatectomy or radiotherapy), when compared to standard care alone.
"The approval of Casodex™ 150mg is important for the thousands of patients who have, until this point, not had access to a drug therapy to treat their cancer until the disease had progressed," said Chris Brinsmead, Vice President, Oncology. "With these first approvals, AstraZeneca is now pleased to offer patients further treatment options across the various stages of prostate cancer."
Further regulatory submissions and approvals are anticipated, including in the US, where a submission is planned by the end of the year. In addition, licences have recently been granted for Casodex™ 150mg in Italy and Hungary, which also authorise its use in the early stages of prostate cancer.
In 2000, Casodex™'s worldwide sales of $433 m showed a 31 percent increase compared to the previous year. Casodex™ is one of five important AstraZeneca products, whose growth is being fuelled by life cycle initiatives.
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Steve Brown +44 (0)20 7304 5033
Emily Denney +44 (0)20 7304 5034
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Mina Blair-Robinson +44 (0)20 7304 5084
Mike Rance +44 (0)20 7304 5050
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- The new indication in the UK, Greece, Portugal and Austria is as follows: "In patients with localised prostate cancer, Casodex 150mg is indicated as immediate therapy in patients who are not being treated by radical prostatectomy or radiotherapy. In patients with locally advanced prostate cancer, Casodex 150mg is indicated as immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy." Many men diagnosed with localised prostate cancer, and who do not have symptoms, are not offered curative treatment. Instead, these patients are carefully monitored for signs that the cancer has progressed. This is known as "watchful waiting" or "active surveillance." The UK Government has recently announced the availability of a test which can detect prostate cancer, the Prostate Specific Antigen (PSA) test, to all men who ask their GPs for it. Physicians say the earlier a cancer is found, the greater the chances of survival for the patient. New research from the Cancer Research Campaign predicts that prostate malignancy will become the most common cause of cancer-related death by 2020 because of the rapidly ageing population, despite it affecting only men. Prostate cancer kills about 10,000 men a year in the UK and approximately 21,000 men are newly diagnosed.
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