Eli Lilly Wins FDA Approval for Breast Cancer Combo, Doubling Survival Results

The U.S. Food and Drug Administration (FDA) granted full approval for Eli Lilly’s Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib).

This all-oral therapy treats adults with advanced or metastatic ER+, HER2-, and ESR1-mutated breast cancer. The treatment is indicated for patients whose disease progressed following endocrine therapy.

The Phase 3 EMBER-3 trial found the combination doubled median progression-free survival compared to monotherapy. Patients using the combination therapy reached a median of 11.1 months before disease progression. Patients taking Inluriyo alone reached a median of 5.5 months.

The regimen targets two central drivers of tumor growth to provide a new treatment approach.