According to Dendreon, in a breakthrough for the prostate cancer community, Provenge, its' experimental treatment vaccine for advanced prostate cancer, successfully met all researchers' goals in a key trial required for FDA approval.

A biologic drug given by infusion, an FDA advisory panel recommended FDA approve Provenge, instead FDA asked for more information on whether the drug that spurs the immune system to fight advanced prostate cancer refusing to respond to anti-androgen treatment, prolonged survival.

Unlike traditional vaccines that prevent disease, Provenge is a therapeutic vaccine that treats cancer by training the immune system to fight tumours. A customized treatment for each patient, specialized cells are collected from each patient's blood, cells which help the immune system recognize cancer as a threat, just as when germs enter the body. Once approved, it will the first such treatment on the market.

FDA's request resulted in a new study of 512-men, who had advanced metastatic, androgen-independent prostate cancer i. e. cancer that had spread without responding to anti-androgen treatment. The study results, 'unambiguous' and 'very consistent' showed that overall survival rates for those taking Provenge were significantly better than those on placebos.

No new side effects from Provenge stood out in the study, though the most common side effects noted in previous trials included low level chills, fever, headache, fatigue, shortness of breath, vomiting, and tremor, for one to two days following infusion.

Dendreon's study results will be submitted to FDA in the last quarter of 2009, giving the agency six months to review the material, and will also present its findings at the American Urological Association's annual meeting in Chicago

The most common non-skin cancer amongst American men, there are an estimated 186,000 new prostate cancer cases each year, with 28,660 deaths from it last year.