18. Sep 2026
Description
(AWP Alliance News) - Eli Lilly secured full FDA clearance for Inluriyo in combination with Verzenio to treat adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. The label requires an FDA-authorized test to detect the ESR1 mutation.
The decision was supported by the Phase 3 EMBER-3 trial, where the combination delivered median progression-free survival of 11.1 months versus 5.5 months with Inluriyo alone.
https://www.prnewswire.com/news-releases/us-fda-approves-inluriyo-imlun…
Disclaimer: This news brief was created using generative artificial intelligence. Eli Lilly and Company published the original content used to generate this news brief via PR Newswire on September 18, 2026, and is solely responsible for the information contained therein.
