Shares of Dendreon have climbed sharply in recent sessions in anticipation of today's meeting of an expert FDA committee on Provenge, its prostate cancer therapy. Dendreon has pent $400 million over 10 years developing the therapy, which is pegged as a potential blockbuster if it gains FDA approval. The company's challenge is persuading the agency that data supporting a longer life for patients taking the drug is cause for overlooking the fact that the therapy missed its primary goal of delaying disease progression. Analysts sound decidedly mixed on Provenge's chances, wondering if the data on longer life is significant enough to warrant more than an "approvable" letter that would require Dendreon to analyze another three years of results from an ongoing study.
- read the report from the Seattle Times