Overview

• The approval covers adults with ER‑positive, HER2‑negative, ESR1‑mutated advanced or metastatic breast cancer after progression on at least one prior endocrine therapy.
• In the ESR1‑mutated cohort of the phase 3 EMBER‑3 trial, Inluriyo reduced the risk of progression or death by 38% versus fulvestrant or exemestane, yielding median PFS of 5.5 vs 3.8 months (HR 0.62).
• The FDA also authorized the Guardant360 CDx liquid biopsy as the companion diagnostic to detect ESR1 mutations for treatment selection.
• Reported side effects were mostly low grade, including decreases in blood counts, musculoskeletal pain, fatigue, diarrhea and nausea, and the label carries an embryo‑fetal toxicity warning.
• Lilly set a U.S. list price of $22,500 for a 28‑day supply and expects availability in the coming weeks, while overall survival results remain immature and larger studies continue.