Dendreon's announcement earlier this week that its cancer vaccine Provenge was a success in a Phase III trial elicited a euphoric response from investors, but a number of experts tell the Financial Times that the Seattle developer still faces some formidable obstacles before it can win an FDA approval.
Several industry insiders and Dr. C.K. Wang, an oncologist at the Cancer Institute of Dallas, say that Dendreon may well be asked to launch a confirmatory Phase III study to back up the new data. This is the first cancer vaccine that will be submitted for an FDA approval, putting Dendreon in unknown territory as far as regulators' appetite for risk.
"My guess is it will get back to ODAC [the Oncology Drugs Advisory Committee], and at that point, depending on who is on the ODAC committee, the reproducibility of the study will be called into question," one industry executive speculated.
Others speculate that Dendreon will also face some steep challenges before its manufacturing process for the new vaccine is approved. And the vaccine could face some heavy resistance from payers if the therapy delivers only a few months of added survival time.
- read the report in the Financial Times