The trial involved 512 patients with metastatic androgen-independent prostate cancer. It was conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration.

 

The drug improved overall survival in men with advanced forms of the disease, bolstering the chances of it becoming the first approved therapeutic vaccine for cancer.

 

The company is expected to present the full data from the study on April 28 at the American Urological Association's annual meeting.

 

“The successful outcome from the Phase 3 IMPACT study provides validation of the long-pursued goal of harnessing the human immune system against a patient's own cancer,” Dendreon Chief Executive Mitchell Gold said in a statement.

 

Provenge is made from a patient’s own cells and administered when the disease no longer responds to hormone blockers. The drug prompts the immune system to attack the cancer and thus is often referred to as a vaccine.

The company will seek regulatory approval for Provenge in the fourth quarter of this year.