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benefits of priority review and orphan status

  1. 701 Posts.
    Here's an example of an oncology drug (prostate) that was recently fast tracked by the FDA.

    It was stopped mid phase 3. It demonstrated a 4.8 month median OS benefit and 5.4mnth PFS. This is a lower benefit than I would have thought to stop the trial early, but due to it's low toxicity it was approved.

    http://www.clinicalleader.com/doc.mvc/xtandi-gets-speedy-fda-ok-metastatic-castration-prostate-cancer-0001
 
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