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  • coolhandsu coolhandsu Apr 22, 2007 12:11 PM Flag

    Wouldn't a full approval make it impossible to complete tests?

    It is a good question. It is possible they'll delay approval pending full enrollment in the trial (no way do they wait for results in 2010), but your concern about keeping patients in the trial is spot on. OTOH, are we going to doom all those placebo patients, and all the ones who won't enroll in trials, just so we can get more efficacy data on something we already believe is safe and effective? The more reasonable approach is to just move on with the research, starting trials that use Provenge and taxotere in various combinations and finishing the existing trial with the patients they have, possibly modifying it to allow all patients to receive Provenge and using historical controls.

    Approve Provenge to move into phase IV post marketing trials, and everyone benefits. A delay hurts too many patients and also hurts the pipeline. The evidence is sufficient for approval now.

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    • I was thinking the same thing last night, but i would assume they use the real patients and study effects on them instead. They still have phase 3 trial advertised on their website, if it disappears or changes it could be a good sign.

    • Wouldn't the Advisory Panel have considered this Question, and thought the better solution would be to approve it. Besides I am sure that the approval will be for LIMITED use in controlled situations and not for general use, while the research and data collection continues.

      • 1 Reply to will_amd_yu
      • Thanks guys for your helpful answers :)
        Here's another great answer convincingly arguing that the missing 35 patients for the control group could easily be enrolled outside of the U.S.:

        Does the FDA deny the approval of Provenge in order to get a more accurate reading of 9902B? Or should the FDA withold this safe and more effective treatment from ~100,000 men over the next few years until the 9902B survival data matures? I firmly believe that the agency and the company can hash out a workable solution, such as establishing a cutoff date for US enrollment, filling the remaining spots in the trial with patients from countries where Provenge won't be approved for several years (Canada, NW Europe, Australia), and approving the treatment for marketing. There is clearly an overwhelming demand in the prostate cancer community for an effective treatment like Provenge that does not have the severe side effect profile characterized by Taxotere chemotherapy.