Some thoughts on the FDA draft guidance on the use of pCR as an endpoint for accelerated approval of treatment in high-risk early-stage breast cancer
Lu Cui, Abbvie Inc *Bo Yang, Abbvie Inc Keywords: Surrogate endpoint, correlation The FDA draft guidance (May 2012): ‘Pathologic Complete Response in Neo-adjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval’ is intended to assist sponsors in designing trials to support marketing approval of the drugs to treat breast cancer in the neo-adjuvant (preoperative) setting. In this talk, the key aspects of this guideline will be outlined. Issues and possible solutions in relation to designing such studies will be explored, and illustrated via computer simulations.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC