The FDA authorized Eli Lilly's imlunestrant (Inluriyo), an oral selective estrogen receptor degrader, for treatment of adults with estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer harboring ESR1 mutations. The approval stems from positive outcomes in the EMBER-3 phase III trial, demonstrating superior progression-free survival compared to endocrine therapies. This marks a significant addition to oral SERD options, following Menarini's Orserdu.