On Sept. 18, 2026, Eli Lilly and Company announced 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.

This full FDA approval is based on the results of the Phase 3 EMBER-3 trial in patients with MBC whose tumors harbor an ESR1 mutation (n=159). Patients received Inluriyo (n=92) or Inluriyo in combination with Verzenio (n=67) after an aromatase inhibitor (AI), with or without a CDK4/6 inhibitor, in either the adjuvant or metastatic setting. Among patients with ESR1-mutated MBC, Inluriyo in combination with Verzenio doubled median progression-free survival (PFS) versus Inluriyo alone, with a median PFS of 11.1 months versus 5.5 months (HR=0.53 [95% CI, 0.35–0.80]).

In about half of patients with ER+, HER2– MBC, tumors develop a genetic change called an ESR1 mutation during or after treatment with a common class of hormone-blocking medicines known as AIs. These mutations can cause estrogen receptors to become overactive, fueling cancer growth. Inluriyo and Verzenio target two different drivers of tumor growth, offering a combined approach to help slow the disease. Inluriyo degrades mutated estrogen receptors, cutting off the signal that drives cancer cells to grow. Verzenio targets proteins that control how quickly cancer cells divide, helping to slow their growth.

In EMBER-3, the majority of adverse events (AEs) with Inluriyo in combination with Verzenio were Grade 1-2. The most common (≥10%) adverse reactions, including laboratory abnormalities, were decreased neutrophils, diarrhea, decreased hemoglobin, decreased lymphocytes, nausea, decreased platelets, fatigue, increased triglycerides, infections, increased AST, increased creatinine, increased ALT, vomiting, musculoskeletal pain, abdominal pain, decreased appetite, increased cholesterol, rash, cough, headache, and decreased weight. Permanent discontinuation of Inluriyo alone due to adverse reactions in the combination arm occurred in 1% of patients, and permanent discontinuation of Verzenio alone in the combination arm occurred in 3.4% of patients.

This marks the second FDA approval for Inluriyo in less than a year, following its September 2025 approval as monotherapy for the treatment of adults with ER+, HER2–, ESR1-mutated MBC whose disease progressed after at least one line of endocrine therapy (ET).