Roche announces U.S. FDA accepted NDA for giredestrant with everolimus

Roche (RHHBY) announced that the United States Food and Drug Administration, FDA, has accepted the company’s New Drug Application, NDA, for giredestrant in combination with everolimus for the treatment of adult patients with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on a prior endocrine-based regimen. The FDA is expected to make a decision on the approval by 18 December 2026. Giredestrant plus everolimus could be the first and only oral selective oestrogen receptor degrader, SERD, combination approved in the post-cyclin-dependent kinase4/6 inhibitor setting. “The clinically meaningful benefit seen with giredestrant could enable an important new treatment option to help delay disease progression or death in people with advanced, ER-positive breast cancer,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “This acceptance marks a first step towards establishing the giredestrant combination as a new standard of care in this population.”