Genentech, a member of the Roche Group ((SIX: RO, ROP, OTCQX:RHHBY), announced today that the United States (U.S.) Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) under Priority Review for giredestrant, an investigational oral selective estrogen receptor degrader (SERD), as an adjuvant treatment for adults with estrogen 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 November 30, 2026.