Waiting Game for Life-Extending Prostate Drug

April 28, 2010— -- Men with severe prostate cancer were given a flicker of hope for a new treatment after the U.S. Food and Drug Administration voted unanimously that a vaccine therapy was safe, and voted 13-4 that substantial evidence exists suggesting that it is effective in treating prostate cancer.

That was three years ago.

But Instead of approving the drug, called Provenge, back in 2007, the FDA sent researchers back to do more studies.

But now, the long delayed vote to approve the drug for use could be days away.

Dr. David Penson, a researcher on the original Provenge studies, said the FDA questioned the curious results of the clinical trials of Provenge.

Provenge didn't perform well on the researchers' goal or "primary endpoint" to slow cancer's growth, Penson said, yet a subset of patients on the treatment lived several months longer than patients on placebo.

"A lot of patients were hopeful in 2007 that the FDA would say 'we don't usually take a secondary endpoint [living longer], but we will here,'" said Penson, professor of urologic surgery, at Vanderbilt University in Nashville, Tenn. "They [FDA] had their responsibility to the public and they were conservative... no use crying over spilled milk."

Penson said a larger study, of 500 men with metastasized, hormone-resistant prostate cancer confirmed the earlier finding that Provenge extends life by an average of four months. Men with that stage of prostate cancer usually have only one treatment option left -- a drug called Docetaxel, which has a "fair number" of side effects compared to Provenge.

Now the FDA is posed to make a final decision on whether Provenge is safe and effective enough for the U.S. market within a week. FDA spokeswoman Shelly Burgess said the FDA cannot comment on pending decisions and therefore could not comment for this article.

The drug is unusual not just for its ability to prolong life for some patients.

Provenge is also said to be the first prostate cancer therapy of its kind that works by overhauling and boosting the body's own immune system to fight cancer. Standard cancer treatments such as chemotherapy or radiation work by obliterating tissues -- mostly diseased but some healthy tissues as well.