Inluriyo plus Verzenio delivers proven clinical benefit after the evidence-based practice of maximizing initial treatment with an aromatase inhibitor, with or without a CDK4/6 inhibitor 

In the Phase 3 EMBER-3 trial, Inluriyo in combination with Verzenio doubled median progression-free survival compared to Inluriyo alone, among patients with ESR1-mutated MBC

The all-oral combination of Inluriyo and Verzenio gives patients a treatment approach that targets the two central drivers of ER+ breast cancer, with an established tolerability profile and no new monitoring required 

INDIANAPOLIS, Sept. 18, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) announced today that the U.S. Food and Drug Administration (FDA) has granted full approval to Inluriyo (imlunestrant), an oral estrogen receptor (ER) antagonist, in combination with Verzenio (abemaciclib), a CDK4/6 inhibitor, for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated locally advanced or metastatic breast cancer (MBC), as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. The approval is based on the proven clinical benefit of switching to Inluriyo in combination with Verzenio at clinical progression as observed in the Phase 3 EMBER-3 trial.