FDA Grants Full Approval to Lilly's Inluriyo-Verzenio Combo for Breast Cancer
Indianapolis – September 20, 2026 -- The U.S. Food and Drug Administration has granted full approval to Eli Lilly and Company's (NYSE: LLY) Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for adults with estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy.
EMBER-3 trial shows combination doubles progression-free survival
The approval rests on Phase 3 EMBER-3 data in 159 patients with ESR1-mutated metastatic breast cancer who had previously received an aromatase inhibitor, with or without a CDK4/6 inhibitor. Patients randomized to Inluriyo plus Verzenio (n=67) achieved a median progression-free survival of 11.1 months, versus 5.5 months for Inluriyo alone (n=92), a hazard ratio of 0.53 (95% CI, 0.35–0.80).