Provenge, made from a patient’s own cells and administered when prostate cancer no longer responds to hormone blockers, prompts the immune system to attack the cancerous cells. If approved, Provenge would be the first therapeutic vaccine on the market.

 

“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.

 

An FDA advisory panel first recommended the vaccine for approval in 2007, but the agency requested more information about whether Provenge prolongs survival.

 

A new study was conducted, on 512 men with advanced prostate cancer, which showed that survival was significantly better for men taking Provenge than those taking a placebo. The trial was conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration.

 

The company is now planning to submit the study’s results to the FDA in the fourth quarter of 2009.

 

“This data supports Provenge being used as front-line treatment in men with metastatic, androgen-independent prostate cancer,” Gold said.

 

Most common side effects of the vaccine were chills, fever, headache, fatigue, shortness of breath, vomiting and tremor, mainly at a low level and for one to two days following infusion.