Indications -- Cancer Message Board

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Biotech / Medical : Indications -- Cancer

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To: Icebrg who wrote (325)	12/18/2002 7:30:48 PM
From: keokalani'nui	Read Replies (1) of 1840

The Oncologist, Capitol Hill report.... The FDA’s oncology division is testing the waters for re-visiting the concept of accelerated approval regulations as they apply to oncology. The division has indicated that issues relative to the limited definition, as well as the structure of clinical development for the agents undergoing the review, need to be considered. The agency believes that it is timely to move toward an emphasis of interim analysis of a surrogate endpoint in a randomized trial rather than relying on nonrandomized phase II trials. The oncology division has granted 11 accelerated approvals through January 1, 2002, and nine of these were based on tumor response in single-arm phase II refractory cancers. They are encouraging a greater use of time to progression rather than tumor response as an endpoint for agents being evaluated under accelerated review. theoncologist.alphamedpress.org

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