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FDA’s Early Breast Cancer pCR Final Guidance Stresses One Trial

 
• By Emily Hayes

Final guidance from FDA on accelerated approval pathway based on pathological complete response in neoadjuvant breast cancer clarifies that one large trial is the “default” for most applications.

FDA’s final guidance on using pathologic complete response as a surrogate endpoint in neoadjuvant breast cancer advocates running a single large study in the pre-operative setting, as opposed to the option for using two or more trials in different settings as laid out in the draft guidance.

FDA published draft guidance in May 2012 that outlined two different ways to get accelerated approval using the pCR endpoint...

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