FDA approves Lilly’s Inluriyo–Verzenio combination for ESR1-mutated breast cancer on September 21, 2026 abemaciclib Approved eli lilly EMBER-3 ER-positive ESR1 gene HER2-negative breast cancer imlunestrant Inluriyo Malignant neoplasm of breast Mutation oral SERD United States Food and Drug Administration Verzenio +