Roche announced the FDA has accepted its New Drug Application for giredestrant plus everolimus. This combination is for adult patients with ER-positive, HER2-negative, ESR1-mutated advanced breast cancer. The FDA’s decision is expected by December 18, 2026. The filing is based on Phase III evERA data. Giredestrant plus everolimus reduced the risk of disease progression or death by 44% in the ITT population. In the ESR1-mutated population, the risk reduction was 62%. Overall survival data showed a positive trend. The combination's adverse events were manageable and consistent with known safety profiles. It could be the first oral SERD approved in the post-CDK4/6 inhibitor setting. The evERA study aimed to help address resistance to endocrine therapies. Further data from other trials will provide additional evidence. The company's development program seeks to provide innovative medicines for ER-positive breast cancer.