Guidance for Industry Pathological Complete Response in Neo-Adjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval.

摘要

This guidance is intended to assist applicants in designing trials to support marketing approval of drugs and biological products for the treatment of breast cancer in the neo-adjuvant (preoperative) setting.2 The main focus of the guidance is to discuss the use of pathological complete response (pCR) in breast cancer as a potential endpoint to support approval under the accelerated approval regulations (21 CFR part 314, sub-part H, for drugs and 21 CFR part 601, sub-part E, for biological products).