The FDA has approved Eli Lilly’s Inluriyo (formerly imlunestrant), an oral selective estrogen receptor degrader (SERD), for treating adults with metastatic, estrogen receptor-positive, HER2-negative breast cancer harboring ESR1 mutations. These mutations, present in about half of such patients after hormone therapy exposure, confer resistance to standard treatments. Approval was based on the EMBER-3 study demonstrating a 38% reduction in disease progression or death compared to hormone suppressants. Inluriyo offers an all-oral treatment alternative to injectable regimens and is part of a growing class of oral SERDs.