The FDA has reversed its long-standing policy regarding breast cancer trials that could greatly reduce the time and cost of new drug development for early-stage breast cancer. Developed in collaboration with the Biomarkers Consortium, a partnership of public and private groups led by the Foundation for the National Institutes of Health, and intended to spur innovation in drug development, the FDA has released a new regulatory guidance that describes a novel pathway for accelerated approval of drugs based on data for certain types of localized, early-stage breast cancer showing complete response (or cure) with neoadjuvant therapy. Up to now, the FDA first reviewed breast cancer drugs for metastatic disease; only after such an indication was received would the drug become eligible to be tested for early-stage disease. This meant that patients with early disease would have to wait years for new and improved therapies to become available.
“Better options for patients with high-risk breast cancer are urgently needed,” said Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research. “The FDA guidance explains how a promising drug identified in trials such as the I-SPY 2 could be evaluated for FDA approval, so patients could have rapid access if the drug proved better than current treatments.” Foundation for the National Institutes of Health, press release, June 1, 2012.
