Posted for Heidi Ledford

A controversial prostate cancer vaccine has become the first therapeutic cancer vaccine to receive regulatory approval in the United States.

On 29 April, the US Food and Drug Administration (FDA) approved Provenge (sipuleucel-T) for the treatment of advanced hormone-resistant prostate cancer. Stock in Dendreon, the vaccine’s Seattle, Washington-based manufacturer, rose 27% on the announcement.

Provenge seemed on the cusp of approval three years ago, but the FDA demanded additional clinical trial data (see Nature 464, 1110-1111; 2010). The vaccine must be tailor-made from a patient’s own immune cells – unlike preventative vaccines, it actively fights prostate cancer after the disease has taken hold. That doesn’t come cheap: the treatment will cost about $93,000 per patient, the company said.