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