Provenge Doc: FDA Has All the Data It Needs

The 4.1-month survival benefit was on the upper end of expectations and exceeds the survival advantage provided by Taxotere, a chemotherapy drug marketed by Sanofi Aventis.

To put these results in perspective, very few cancer drugs can make the claim of a survival benefit greater than four months. Only one drug has had that kind of impact recently -- Genentech's Avastin, which improved survival in advanced colon cancer patients by 4.7 months.

"I'm already getting calls weekly from patients wondering when Provenge will be approved," said Penson.

Dendreon CEO Mitch Gold said the company would re-file Provenge with the FDA in the fourth quarter.

"The results of the [Provenge] study are unambiguous," said Gold on a company conference called Tuesday night, adding that if the FDA takes six months to review Provenge again, the drug could be on the market in the middle of 2010.

The IMPACT study enrolled 512 men with advanced prostate cancer who no longer responded to hormone therapy. The primary endpoint of the study was to determine whether treatment with Provenge prolonged overall survival of patients compared to a placebo.

Dr. Robert Reiter, a professor of urology at the UCLA Jonsson Comprehensive Cancer Center and a self-described Provenge skeptic was in the audience to see the Provenge presentation, and walked away impressed.