FDA green light for Lilly’s Inluriyo

The US Food and Drug Administration (FDA) yesterday approved Eli Lilly’s (NYSE: LLY) Inluriyo (imlunestrant, 200mg tablets), an oral estrogen receptor antagonist, 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).

The US pharma major noted that, in the Phase III 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 (PFS) versus fulvestrant or exemestane, with a median PFS of 5.5 months versus 3.8 months (HR=0.62 [95% CI: 0.46-0.82]); p-value=0.0008.