FDA accepts New Drug Application for Roche’s giredestrant in ER-positive early-stage breast cancer, the first and only oral SERD with positive phase III results in the curative setting

The FDA has accepted Roche's New Drug Application for giredestrant, an oral selective estrogen receptor degrader (SERD), for treating ER-positive, HER2-negative early-stage breast cancer under priority review. Phase III lidERA trial data showed giredestrant reduced the risk of invasive disease recurrence or death by 30% compared to standard-of-care endocrine therapy, representing the first major advance in adjuvant endocrine therapy in over 20 years. An FDA decision is expected by November 30, 2026.