The U.S. FDA has approved Eli Lilly's imlunestrant (Inluriyo), an oral selective estrogen receptor degrader (SERD), for adults with estrogen receptor-positive, HER2-negative, ESR1-mutant advanced or metastatic breast cancer. This second-line treatment demonstrated superior progression-free survival and overall survival compared to standard endocrine therapies in the Phase III Ember-3 trial. The approval reinforces Lilly's expanding oncology portfolio.