NEJM lays out questions--and facts--about Provenge

Shares of Dendreon (NASDAQ: DNDN) soared into the stratosphere in the lead-up to Provenge's approval--and then promptly started tumbling fast as all sorts of questions arose about supply issues and efficacy. The company is likely to benefit enormously from the publication of its biggest study of the innovative prostate cancer vaccine in the prestigious New England Journal of Medicine, which carries biblical weight with providers.

The facts about the Provenge data have been known for some time; the drug demonstrated a 22.5 percent reduction in the risk of death and a 4.1 month increase in median survival rates compared with a placebo. Earlier stage patients benefited with significantly longer survival rates. Forbes' Matthew Herper notes that it's significant that the survival data is consistent, and he offers kudos for getting Dana Farber's well-respected Philip Kantoff as the lead author.

"These results represent the beginning of a new era in the treatment of cancer, one in which a patient's own immune system is harnessed to fight the disease," says Kantoff in a statement. "Furthermore, the magnitude of the survival benefit coupled with the side effect profile and short duration of therapy place Provenge as a new standard of care for men with asymptomatic or minimally symptomatic mCRPC."

But there was also some skepticism about the new drug. In particular, Herper notes, the study raises questions about the drug's benefit, including the absence of a "measurable effect on tumors." Dan Longo, a deputy editor at the New England Journal of Medicine, calls that "hard to understand" in an accompanying editorial.

Provenge is also radically more expensive than current prostate cancer therapies. At $93,000, physicians and payers will have to question a drug that costs $23,000 a month versus the $1,800 monthly fee they currently face.

- check out the press release
- here's Herper's report in Forbes
- read the story from TheStreet