FDA approves Lilly’s Inluriyo for type of advanced or metastatic breast cancer

Eli Lilly (LLY) announced that the U.S. Food and Drug Administration has approved Inluriyo, an oral estrogen receptor antagonist, for the treatment of adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. In the Phase 3 EMBER-3 trial, Inluriyo reduced the risk of progression or death by 38% versus ET. Among patients with ESR1-mutated MBC, Inluriyo significantly improved progression-free survival versus fulvestrant or exemestane, with a median PFS of 5.5 months vs 3.8 months. Inluriyo is a treatment for ER+, HER2-, ESR1-mutated MBC. Some breast cancers develop ESR1 mutations that can cause estrogen receptors to become overactive and drive cancer growth. Inluriyo binds, blocks, and facilitates the degradation of these receptors, helping to slow disease progression. Its once-daily dosing provides patients with an oral treatment option. The Inluriyo label contains a warning and precaution for embryo-fetal toxicity.