FDA Grants Priority Review for New Breast Cancer Drug Application

The U.S. FDA has accepted Roche's New Drug Application for giredestrant, an investigational oral selective estrogen receptor degrader, under Priority Review. This application is for its use as an adjuvant treatment for ER-positive, HER2-negative, early-stage breast cancer. A decision is anticipated by November 30, 2026, potentially offering a new endocrine therapy option for patients.