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《5α-還原酶抑制劑對前列腺癌的化學(xué)預(yù)防指南》內(nèi)容預(yù)覽

    ASCO/AUA Special Announcement on FDA Decision Re:Dutasteride

    Special Announcement （2/22/11）： On January 26, 2011 FDA issued a Complete Response letter for thesupplemental New Drug Application for dutasteride for prostate cancer chemoprevention. A CompleteResponse letter is issued by the FDA's Center for Drug Evaluation and Research when the review of a file is completed and it cannot be approved in its present form. The notification refers only to the supplemental fileregarding an indication to reduce prostate cancer risk and not the existing FDA-approved uses. Dutasteride iscurrently approved to treat symptomatic benign prostatic hyperplasia （BPH） in men with an enlargedprostate.

    In December, 2010, the FDA's Oncologic Drugs Advisory Committee （ODAC） voted against recommendingdutasteride （Avodart, GlaxoSmithKline） for the indication to reduce prostate cancer risk because in the view of the ODAC members, the risk for more aggressive tumors out weighed the potential for chemoprevention.ODAC recommended against prostate cancer chemoprevention labeling for the 5-alpha reductase inhibitors -dutasteride （vote 14 （no） to 2 （yes）， with 2 abstentions） and finasteride （vote 17 （no） to 0 （yes）， with1abstention）。

    As part of ASCO's scheduled updates to its guidelines, an ASCO-AUA Update Panel for the Clinical PracticeGuideline published in 2008, “Use of 5-alpha Reductase Inhibitors for Prostate Cancer Chemoprevention” will convene shortly and will consider all the evidence bearing on the question of 5-ARIs for chemoprevention ofprostate cancer, including the data and discussions that occurred at the ODAC meeting.

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