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Prostate Cancer Provenge Strong in Trial

Treatment Vaccine Improved Survival in Men With Advanced Prostate Cancer

FDA Move Prompted Protests

The FDA considered, and rejected, such a request two years ago in a move that angered prostate cancer patients and patient advocates.

Considering evidence from the first two trials, an FDA board concluded that Dendreon had failed to prove that Provenge was both safe and effective.

The decision reportedly led to protests outside FDA headquarters by patients and company investors, and to death threats directed at board members who voted against approval.

It also led to the newly published trial, which Brawley says addresses many of the concerns about Provenge, if, as he says, “the results hold up to scrutiny.”

“I do believe this is the trial that needed to be completed in order to approve this treatment,” he says. “If it had been approved after the last FDA hearing there would have been a lot of questions that never would have been answered. I have seen the harm done when a bad drug is approved without adequate evaluation.”

Biostatician Donald Berry, MD, of Houston’s University of Texas M.D. Anderson Cancer Center, tells WebMD that the three studies together suggest that patients do benefit from the novel treatment. But he characterized the benefits as “marginal.”

“This is not the magic bullet that we had hoped for to cure cancer,” he says. “It is not a panacea.”

Treatment Offers Hope

But prostate cancer patients who attended Tuesday's news conference said the new treatment offers hope to patients who currently have little.

Nine-year prostate cancer survivor Thomas Farrington said many advanced cancer patients with no other treatment options reject or stop chemotherapy because of the side effects.

Patient Jim Kiefert, of the prostate cancer education and support group Us Too, said most patients he knows would embrace a treatment with minimal side effects for the chance to gain even a few extra months of life.

“This is additional hope that men need when they are at that last stage of prostate cancer,” he says.


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