On September 25, 2025, the FDA approved imlunestrant (Inluriyo™, Eli Lilly and Company) and a companion diagnostic test for the treatment of people with ER-positive, HER2-negative advanced or metastatic breast cancer with an ESR1 gene mutation who have received at least one type of hormone therapy. This approval is based on results from the phase III EMBER-3 clinical trial.
Imlunestrant (Inluriyo™) for ER+, HER2-, ESR1-mutated MBC
- US Food and Drug Administration: FDA approves imlunestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
Clinical Trials for Imlunestrant (Inluriyo™)
- Metastatic Trial Search: Trials for Imlunestrant (Inluriyo™)
Last Modified on October 30, 2025