Panel Recommends FDA Approve Prostate Cancer 'Vaccine'

March 30, 2007— -- A Food and Drug Administration (FDA) advisory panel announced Thursday that a new treatment designed to turn the body's own immune system against deadly prostate cancer tumors is both safe and effective.

The 17-member panel voted unanimously that the drug is safe, and 13-4 that substantial evidence exists suggesting that it is effective in treating prostate cancer.

The decision, though not officially binding, could pave the way for the treatment's consideration by the FDA as a standard therapy for certain cases of prostate cancer.

The treatment, called Provenge, was developed by Seattle's Dendreon Corp. It is the first in what many hope could be a new line of cancer treatments known as "active cellular immunotherapy."

In essence, the treatment trains the body's own immune cells to recognize and attack existing prostate cancer cells.

And though Thursday's advisory panel meeting in Washington, D.C. was just the first step toward FDA approval, some experts in the field are already hopeful that the therapy could open up a new chapter in the fight against prostate cancer.

"The technology is innovative and exciting," says Dr. E. Roy Berger, a prostate cancer specialist at John T. Mather Memorial Hospital in Port Jefferson who is involved in the clinical research for the treatment.

"We now have two arrows in the quiver other than hormones when treating prostate cancer."

Dr. Johannes Vieweg, chair of urology at the University of Florida in Gainesville and an expert in immunotherapy, is not directly involved with the research on Provenge. But he says he is "delighted" that the advisory panel rendered a favorable decision.

"This is the first-ever cancer vaccine that targets established tumors," Vieweg says. "If this drug is approved, it will just open up more investigation in this area."

However, he says that the treatment still faces obstacles before it becomes a regular offering in prostate cancer treatment.

"This is not ready for too much excitement yet," he says. "The drug has been shown to prolong survival in these patients by four and a half months. This is a very good result, but the issue is that more studies have to occur now to determine the true benefits."