Inluriyo (imlunestrant) - (EMBER-3)

Sept. 18, 2026: Eli Lilly and Company (NYSE: LLY) said the FDA granted full approval to Inluriyo (imlunestrant) plus Verzenio (abemaciclib) for adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer, as detected by an FDA-authorized test, after progression following at least one line of endocrine therapy.

The approval was based on the Phase 3 EMBER-3 trial in ESR1-mutated MBC patients (n=159). Among patients treated after an aromatase inhibitor, with or without a CDK4/6 inhibitor, Inluriyo plus Verzenio (n=67) doubled median progression-free survival versus Inluriyo alone (n=92): 11.1 months vs 5.5 months (HR=0.53; 95% CI, 0.35–0.80). Lilly said the safety profile was consistent with the individual drugs; most adverse events were Grade 1-2. Common adverse reactions included neutrophil decreases, diarrhea, anemia, lymphocyte decreases, nausea, thrombocytopenia, fatigue, elevated triglycerides, infections, AST/ALT increases, creatinine increases, vomiting, musculoskeletal pain, abdominal pain, decreased appetite, cholesterol increases, rash, cough, headache, and weight loss.

Lilly noted this is the second FDA approval for Inluriyo, following its September 2025 monotherapy approval in ESR1-mutated metastatic breast cancer. The company also said Phase 3 EMBER-4 in adjuvant ER+, HER2-negative early breast cancer is ongoing, with initial results anticipated in 2027.