Posted by Michael Wonder on 30 Jul 2020
Pathological complete response in neo-adjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval
29 July 2020 - This guidance is intended to assist sponsors in designing trials to support marketing approval of medicines and biological products for the treatment of high-risk early-stage breast cancer in the neo-adjuvant (preoperative) setting.
The main focus of the guidance is to discuss the use of pathological complete response (pCR) in high-risk early-stage breast cancer as a potential endpoint to support approval under the accelerated approval regulations (21 CFR part 314, subpart H, for new drug applications and 21 CFR part 601, subpart E, for biologics license applications).
