Genentech's Giredestrant NDA Accepted

F. Hoffmann-La Roche — Genentech>>>, a member of the Roche Group, announced that the United States — Food and Drug Administration>>> (FDA) has accepted its New Drug Application (NDA) for giredestrant under Priority Review. Giredestrant is an investigational oral selective estrogen receptor degrader (SERD) intended 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 approval by November 30, 2026. This filing acceptance is based on positive Phase III lidERA Breast Cancer study results, which showed giredestrant significantly reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy. Levi Garraway>>>, F. Hoffmann-La Roche — Genentech>>>'s chief medical officer, highlighted giredestrant as the first major endocrine therapy advance in early-stage ER-positive breast cancer in decades, with the potential to change the treatment paradigm.