Guidance May Help Companies Get Breast Cancer Drugs to Market Faster

Drugmakers could bring breast cancer treatments to market a decade earlier with new FDA guidance on trial designs for evaluating pathologic complete response (pCR) to support accelerated approval of drugs to treat high-risk, early-stage breast cancer. By using randomized neoadjuvant trials assessing a pCR endpoint, sponsors may be reasonably likely to predict clinical benefit within several months of initiating treatment with an investigational drug, the FDA said in a May 29 draft guidance.
Washington Drug Letter