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

Basel, 02 June 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the United States (US) Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) under Priority Review for giredestrant, an investigational oral selective oestrogen receptor degrader (SERD), as an adjuvant treatment for adults with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, stage I, II, and III breast cancer. The FDA is expected to make a decision on the approval by 30 November 2026.