LLY · News · 20260918N

Regulatory Approval Milestones

ELI LILLY & Co · 2026-09-18 · Importance 47 · Surprise 60 · In source text

The FDA granted full approval for Inluriyo (imlunestrant) combined with Verzenio (abemaciclib) in adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer. The indication covers patients whose disease progressed after at least one line of endocrine therapy and requires detection with an FDA-authorized test. In the Phase 3 EMBER-3 trial, the combination doubled median progression-free survival versus Inluriyo alone, supporting Lilly’s oral oncology treatment positioning.

Key facts

• The U.S. Food and Drug Administration has granted full approval to Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for the treatment of adults with ER+, HER2-, ESR1-mutated locally advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. source

Impact estimates