Yes. On September 18, 2026, the U.S. Food and Drug Administration granted full approval to Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for adults with estrogen receptor–positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after disease progression on at least one line of endocrine therapy.
In the Phase 3 EMBER-3 trial, among patients whose tumors carried an ESR1 mutation, the combination roughly doubled median progression-free survival compared with Inluriyo alone (11.1 months versus 5.5 months). Eli Lilly said the all-oral regimen is now available in the United States.
Source: Eli Lilly / PR Newswire, September 18, 2026 (FDA approval announcement).