FDA Breast Cancer Guidance Paves Way For Accelerated Approval With One Trial

FDA’s draft guidance on use of pathological complete response to support accelerated approval of drugs for neoadjuvant treatment of breast cancer lays the groundwork for using only one clinical trial, with response rate as a surrogate endpoint and an extension to look at survival to fulfill the requirement for confirmatory evidence.

The draft guidance issued May 29 addresses accelerated approval of drugs for early-stage, high-risk breast cancer in the neoadjuvant setting (before surgery) as add-on treatment to regimens typically given post-operatively, with the goal of enabling sponsors to use pathologic complete response rate (pCR)