Dendreon plays waiting game as Provenge deadline looms

Sometime by the end of tomorrow, the FDA should deliver its final decision on Dendreon's (NASDAQ: DNDN) Provenge, a potential breakthrough therapeutic cancer vaccine. (The official deadline is on Saturday.) In the meantime, the Seattle-based developer has reaped a bumper crop of news reports focused on the potential benefits the therapy could offer prostate cancer victims. Virtually every major news outfit in the country--along with a host of smaller media outlets--has previewed the therapy in the past week.

"It is certainly exciting to see a drug that has made it this far and appears on the threshold of approval," Dr. J. Len Lichtenfeld, the deputy chief medical officer of the American Cancer Society, tells HealthDay.

Dendreon has had to battle back from a three-year delay in its original schedule for a decision after the FDA ignored an expert panel recommendation for approval and demanded another late-stage study of the cancer vaccine. In patients with advanced prostate cancer, the therapy generated new data demonstrating a modest improvement in survival without slowing disease progression. Doctors may also use it at an earlier disease stage, though, when it could prove more beneficial.

If it is approved, Provenge will become the key trendsetter for all the rest of the therapeutic vaccines in the pipeline. The vaccine is made with a patient's own white cells, and at an expected cost of $75,000 in return for an average 4.5 months of extra life, Provenge will test just how much insurers are willing to pay for incremental cancer benefits.  

- here's the story from HealthDay