FDA Approves Eli Lilly's Inluriyo (Imlunestrant) with Verzenio (Abemaciclib) for ESR1-Mutated Advanced Breast Cancer; Median PFS 11.1 vs 5.5 Months in EMBER-3 Subgroup
The FDA approved Eli Lilly's Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) on Friday, September 18, 2026 for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. The FDA also approved the Guardant360 CDx assay as the companion diagnostic for detecting ESR1 mutations. The approval rests on the EMBER-3 trial, which enrolled 874 adults; in the 159-patient ESR1-mutated subgroup, median progression-free survival was 11.1 months with the combination versus 5.5 months with imlunestrant alone (hazard ratio 0.53). Objective response rates were 35% and 15%, respectively.