Provenge, an experimental treatment vaccine for advanced prostate cancer, met researchers' goal in a key trial needed for FDA approval. That news comes from Dendreon, the company that makes Provenge. "We believe this is truly a breakthrough for the prostate cancer community and a testament to the promise of the field of cancer immunotherapies," Dendreon's president and chief executive officer Mitchell Gold, MD, said in a conference call today.
Provenge is a biologic drug given by infusion to spur the immune system to fight advanced prostate cancer that doesn't respond to anti-androgen treatment. In 2007, an FDA advisory panel recommended that the FDA approve Provenge. But instead, the FDA requested more information about whether Provenge prolongs survival. That request led to a new study of 512 men with advanced prostate cancer. Those men had metastatic, androgen-independent prostate cancer, meaning their cancer had spread and wasn't responding to anti-androgen treatment. In that study, overall survival was significantly better for men taking Provenge than those taking a placebo.