The US Food & Drug Administration (FDA) has approved Dendreon Corporation’s PROVENGE for the treatment of men with advanced prostrate cancer.

The drug, designed to induce an immune response against prostatic acid phosphatase, is the first autologous cellular immunotherapy.

Three phase III clinical studies involving 737 patients have been submitted to the FDA seeking clearance.

Serious adverse events reported from the clinical studies include acute infusion reactions and cerebrovascular events, and Dendreon plans to conduct a registry of 1,500 patients to evaluate a small potential safety signal of such events.