Regulators in the USA have taken a historical step by giving the green light to Dendreon’s prostate cancer vaccine Provenge.

The US Food and Drug Administration has approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease. Not, therefore, a vaccine in the traditional sense, Provenge is an autologous cellular immunotherapy, whereby each dose is manufactured by obtaining a patient’s immune cells which are then exposed to a protein that is found in most prostate cancers. After this process, the cells are returned to the patient to treat the cancer.

The agency has given the go-ahead on the basis of a study of 512 patients which showed an increase in overall survival of 4.1 months for patients receiving Provenge (25.8 months) compared to 21.7 months for those who did not receive the treatment. To fulfill a post-marketing requirement, Dendreon will conduct a registry of 1,500 patients “to further evaluate a small potential safety signal” – in four trials, cerebrovascular events were observed in 3.5% of patients using Provenge compared with 2.6% in the control arm.

Chief executive Mitchell Gold said the approval is “the culmination of nearly 15 years of R&D” and “marks Dendreon's transformation into a commercial enterprise, ready to support the successful launch of the first personalised treatment for cancer”. The company intends to make Provenge available through 50 centres, and will increase capacity over the next year at its New Jersey facility. Two other plants in Atlanta and Orange County, California will be expanded in mid-2011 and the price has been set at $93,000.

Unsurprisingly, Dendreon shares soared on the news and specialists have greeted the approval with enthusiasm. Philip Kantoff of the Dana-Farber Cancer Institute in Boston and a lead investigator of the aforementioned study, said it represents “a significant scientific and clinical advancement”.He added that “cancer immunotherapies that use the patient's own immune system will likely create an entirely new treatment paradigm”.