The FDA has cleared Eli Lilly's oral selective estrogen receptor degrader (SERD) Inluriyo (formerly imlunestrant) for treatment of adults with metastatic, estrogen receptor-positive, HER2-negative breast cancer harboring ESR1 mutations who have progressed on hormone therapy. Approval follows favorable Phase III EMBER-3 trial results showing a 38% risk reduction in disease progression or death compared to standard hormonal treatments. Inluriyo offers an all-oral option for patients with this specific genetic profile and adds to new oral agents challenging older injectable SERDs. The treatment has manageable low-grade side effects and is priced at $22,500 monthly in the US.