The U.S. FDA has approved Eli Lilly’s (NYSE:LLY) imlunestrant, under the brand name Inluriyo, as a second-line therapy for ER+, HER2–, and ESR1-mutated advanced or metastatic breast cancer.
The oral estrogen receptor antagonist won approval based on results from the phase 3 EMBER-3 trial which found that Inluriyo cut the risk of progression or death by 38% compared to endocrine therapy.
In patients with ESR1-mutated breast cancer, those on Inluriyo had a median progression-free survival of 5.5 months vs. 3.8 months with fulvestrant or exemestane.
Inluriyo is in another phase 3 trial examining the treatment in an adjuvant setting for individuals with ER+, HER2– early breast cancer.
