AstraZeneca files for early use of Casodex

AstraZeneca has filed for approval of its once-daily antiandrogenCasodex 150mg (bicalutamide) as a treatment for localized and locally advanced prostate cancer in the UK. This is the first regulatory submission for use of the drug in early prostate cancer, and has been filed two years ahead of schedule, according to the firm.

The submission to the UK Medicines Control Agency is based on the results of AstraZeneca's Early Prostate Cancer Program, which comprises three clinical trials involving over 8,000 patients. Results from one of these studies will be presented at the European Association of Urology meeting in Geneva, Switzerland, on April 8. The EPC Program was set up to examine whether adding Casodex to standard care in patients presenting with early-stage disease (watchful waiting, radical prostatectomy or radiotherapy) could reduce the risk of disease progression and improve survival when compared to standard care alone.

Casodex has been on the market since 1995, but has latterly been enjoying strong growth, fueled by extensions to its approved indications. Last year, the drug's sales rose 31% to $433 million, and approval in early prostate cancer is expected to add a significant upside.