Key insights
- The FDA has granted full approval to Eli Lilly's Inluriyo in combination with Verzenio for adults with a specific type of advanced or metastatic breast cancer. This approval, based on the EMBER-3 trial, showed the combination doubled median progression-free survival compared to Inluriyo alone. This marks a significant advancement for patients with ESR1-mutated breast cancer who have progressed on prior endocrine therapy.
INDIANAPOLIS - Eli Lilly and Company (NYSE:LLY) announced today that the U.S. Food and Drug Administration has granted full approval to Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for treating adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated locally advanced or metastatic breast cancer, according to a press release statement.
The approval applies to patients whose disease progressed following at least one line of endocrine therapy, as detected by an FDA-authorized test.
The approval is based on results from the Phase 3 EMBER-3 trial involving 159 patients with metastatic breast cancer harboring an ESR1 mutation. The trial compared Inluriyo alone (92 patients) to Inluriyo combined with Verzenio (67 patients). The combination doubled median progression-free survival to 11.1 months versus 5.5 months for Inluriyo alone, with a hazard ratio of 0.53.
Patients in the trial had received prior treatment with an aromatase inhibitor, with or without a CDK4/6 inhibitor, in either the adjuvant or metastatic setting.
The most common adverse reactions in the combination arm included decreased neutrophils, diarrhea, decreased hemoglobin, decreased lymphocytes, nausea, decreased platelets, fatigue, and infections. Most adverse events were Grade 1-2. Permanent discontinuation of Inluriyo occurred in 1% of patients in the combination arm, while permanent discontinuation of Verzenio occurred in 3.4%.
This marks Lilly’s second FDA approval for Inluriyo in less than a year. The drug received its initial approval in September 2025 as monotherapy for the same patient population.
Inluriyo is an oral estrogen receptor antagonist that degrades mutated estrogen receptors. Verzenio targets proteins controlling cancer cell division. The combination addresses two drivers of tumor growth in ER-positive breast cancer.
The combination is now available in the United States.
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