US FDA approves Lilly Inluriyo — Verzenio combo for ESR1 — mutated metastatic breast cancer

FDA granted full approval for Inluriyo (imlunestrant) with Verzenio (abemaciclib) in ESR1-mutated ER+, HER2- advanced breast cancer. Label covers adults with progression following at least one line of endocrine therapy, with mutation confirmed by an FDA-authorized test. EMBER-3 trial showed median PFS of 11.1 months vs 5.5 months on Inluriyo alone; HR 0.53. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Eli Lilly and Company published the original content used to generate this news brief via (Ref. ID: 202609181354PR_NEWS_USPR_____DE50868) on September 18, 2026, and is solely responsible for the information contained therein. (C)