FDA approves Lilly’s Inluriyo–Verzenio combination for ESR1-mutated breast cancer

The FDA granted full approval on September 18, 2026, to Eli Lilly’s Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib).

The regimen is for adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy—generally a second-line setting.

Approval was supported by the Phase 3 EMBER-3 trial. In patients with ESR1-mutated disease, median progression-free survival was 11.1 months with the combination versus 5.5 months with Inluriyo alone, representing a 47% reduction in the risk of progression or death.

The FDA also approved Guardant360 CDx as a companion diagnostic to identify ESR1 mutations eligible for treatment.

The recommended doses are Inluriyo 400 mg orally once daily and Verzenio 150 mg twice daily; the combination is available in the United States.

The approval expands Lilly’s oral SERD strategy and provides an all-oral option for a biomarker-defined group of patients after endocrine-therapy progression.