AstraZeneca filed the sNDA with the FDA for Casodex 150mg on 20 December 2001. The FDA grants priority review to those products which may offer significant improvements in the treatment of a disease. Products granted priority review status are generally reviewed within six months, which potentially allows earlier patient access.

“AstraZeneca is pleased by the FDA’s decision to grant Casodex 150mg priority review and we will continue to work closely with the agency in their review of this sNDA,” said Dr. Gerard T. Kennealey, Vice President of Oncology Research at AstraZeneca. “If this new indication for Casodex 150mg is approved, it will be the first medication approved for the adjuvant treatment of early stage prostate cancer.”

The sNDA submission is based upon the first analysis of the combined efficacy and tolerability data from the Early Prostate Cancer (EPC) Programme, which shows that Casodex 150mg not only nearly halves the risk of tumour progression or recurrence, but also reduces the risk of developing bone metastases by a third. These results suggest that Casodex 150mg may be used in treatment of early prostate cancer just as tamoxifen is used to treat breast cancer.

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 twelve countries*. In 2001, Casodex’s worldwide sales of $569 million showed a 31 percent increase compared to 2000. Casodex’s growth is being fuelled by life cycle initiatives towards megabrand status within AstraZeneca’s range of products.