Global pharmaceutical company Eli Lilly and Company (NYSE:LLY) announced on Thursday that it has received approval from the US Food and Drug Administration for Inluriyo (imlunestrant, 200 mg tablets).

The product is an oral estrogen receptor antagonist, intended for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease progressed after at least one line of endocrine therapy (ET).

During the Phase 3 EMBER-3 trial, Inluriyo decreased the risk of progression or death by 38% compared to ET. Among patients with ESR1-mutated MBC, the drug significantly improved progression-free survival (PFS) compared to fulvestrant or exemestane.

Inluriyo was approved by the FDA based on the outcome of the EMBER-3 trial. It is expected to be available in the United States in the coming weeks.