Eli Lilly's Inluriyo wins second FDA approval as combination doubles trial survival data
The approval pairs Inluriyo with Verzenio in an all-oral combination for ESR1-mutated metastatic breast cancer.
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Eli Lilly said Friday the FDA has approved Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for adults with ER+, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, the company said in a release. In the Phase 3 EMBER-3 trial, the combination doubled median progression-free survival compared with Inluriyo alone, according to Eli Lilly.
It is the second FDA approval for Inluriyo in under a year. The drug first won clearance on September 25, 2025, as a monotherapy for the same patient population after at least one prior line of endocrine therapy. That approval rested on EMBER-3 data showing a median progression-free survival of 5.5 months for Inluriyo versus 3.8 months for fulvestrant or exemestane, a hazard ratio of 0.62, according to Eli Lilly investor relations.
In a December 2025 update on the trial program, a principal investigator described median progression-free survival of 11 months in this patient population as "among the longest we've seen," according to Eli Lilly.
The doubled survival data validate Eli Lilly's breast cancer strategy and mark a second regulatory win for Inluriyo within a year, adding to clinical momentum in precision medicine as the company continues to expand its oncology pipeline through acquisitions. The current market backdrop of rising yields and broad sector selling limits how much the news can lift the stock today.