Dendreon Corp fka DNDNQ

[titan3]

march nytimes

...Dendreon tested Provenge in men who had prostate cancer that had spread to other parts of the body and was no longer being controlled by hormone therapy, but was also not causing symptoms. Roughly 50,000 men in the United States are in this category, and they generally survive only a year or two, Dr. Christopher Logothetis of M. D. Anderson Cancer Center, a consultant to Dendreon, told the panel.

Only one drug has been shown to lengthen the lives of these men: the chemotherapy drug Taxotere, also called docetaxel, which has extended survival by about two and a half months. But it has severe side effects, and many men opt not to use it.

In its main trial, Provenge extended median survival by 4.5 months — to 25.9 months for the treated patients versus 21.4 months for those receiving a placebo. After three years, 34 percent of patients who got Provenge were alive compared with 11 percent of those who got a placebo. Provenge also had generally mild side effects like fever and chills, though there was some signs it could raise the risk of strokes.

Still, skeptics on the committee pointed out that the main trial was small, only 127 patients. A second trial, even smaller, showed a survival advantage of 3.3 months, but that was not statistically significant.

Moreover, the goal of both trials had been to show that the drug stopped the advance of the cancer, which it did not. The F.D.A. reviewers raised questions about whether the survival results might have occurred just by chance.

So even as they voted that the drug looked effective, most panel members expressed some reservations.

Richard J. Chappell, a University of Wisconsin biostatistician and a committee member, voted against the drug’s efficacy. “I realize the need for hope,” Dr. Chappell said, “but I don’t want to give the hope on a false premise.”

Other panel members urged approval, especially given the novel nature of the treatment. “New fields are hard to foray into if we wait till everything’s perfect,” said Sharon Terry, a consumer representative on the committee.

About a dozen prostate cancer patients or advocates implored the committee to look past statistical rigidities and consider their plight.

“This kind of drug, Provenge, is all I can think of right now to give me hope,” said Steve Fleischmann of Seattle, who said he hoped to survive his prostate cancer to see his two young children grow up. “What is the harm of approving a drug that has been shown to let men live longer?”

To make the treatment, Dendreon mixes the patient’s immune system cells with a genetically engineered protein that is a combination of an immune booster and a molecule often found in prostate cancer cells but rarely elsewhere in the body. When the cells are put back into the patient’s body, they are thought to stimulate the immune system to attack any cells bearing the telltale molecule — meaning mainly the tumor. Three treatments are needed, two weeks apart.


http://www.nytimes.com/2007/03/30/health/30vaccine.html?ex=1180324800&en=607c47533447186e&ei...