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FDA colorectal cancer endpoints meeting

Executive Summary

FDA will hold a public workshop on clinical trial endpoints for colorectal cancer Nov. 12. 1Draft questions for discussion include whether an increase in disease-free survival compared to standard therapy could be regular and/or accelerated approval standard in an adjuvant setting. For the first-line treatment setting, "is survival the only acceptable endpoint for supporting the approval of drugs for first-line treatment of colon cancer?" FDA asks. Issues identified at the workshop will be further discussed at a meeting of FDA's Oncologic Drugs Advisory Committee and "thereafter will be detailed in FDA guidance documents," the 2workshop announcement says. The meeting will be held from 8 a.m.-5 p.m. at the Marriott Wardman Park Hotel in Washington, D.C...

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