NBC Nightly News (4/29, story 3, 2:00, Williams) reported that “the FDA has approved” Provenge (sipuleucel-T), “a vaccine for prostate cancer. It doesn’t prevent the disease, so vaccine is a bit of a misnomer, ..it could be a game-changer.” The the media hype goes on: “It could help as many as 100,000 men with advanced prostate cancer,” the CBS Evening News (4/29, story 7, 2:00, Katie Couric) reported. It offers “a new way to attack the disease which could be deployed against other kinds of cancer,” ABC World News (4/29, story 7, 1:55, Diane Sawyer) reported. But this is typical media hype, unsupported pure speculation.
The AP reports that “three years ago…the FDA delayed a decision on the treatment, “despite an expert panel’s recommendation for approval.” According to the Los Angeles Times “agency officials were concerned that, even though the vaccine extended lifespan in men with metastatic cancer who did not respond to hormone-deprivation therapy…it did not slow tumor growth.” The FDA also said that too few men given Provenge had been studied and asked Dendreon to perform a larger trial in more than 500 men.
Those results were presented last year, see TheWashington Post. During the trial, which involved “512 patients with advanced prostate cancer, Provenge increased overall survival by about four months, boosting median survival from 21.7 months to 25.8 months.”
The New York Times (4/30, A13, Pollack) reports that “a full treatment (with Provenge) will cost $93,000. Dendreon officials defended that price, saying it was in line with those of other cancer drugs in terms of cost per extra month of life provided by the drug.”
Bloomberg News said that the treatment “will initially be available at about 50 sites used for clinical trials, and more widely distributed after four plants are cleared for use by mid-2011, Seattle-based Dendreon said in a statement.”
But why did the FDA approve the drug without further testing? It’s increasingly clear that public pressure for life-extending new drugs for cancer is irresistible. Would you like to take a chance on 4 miserable months for $23,000 a month, on the basis of this single study? Tough question. Is it time to load up on Dendreon stock?