FDA Approves Inluriyo for Advanced Breast Cancer

By Lori Solomon HealthDay Reporter

Posted on September 2025

Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 1, 2025.

TUESDAY, Sept. 30, 2025 — The U.S. Food and Drug Administration has approved Inluriyo (imlunestrant), 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 (ET).

Inluriyo (200 mg tablets) is approved for once-daily, oral dosing. It binds, blocks, and facilitates the degradation of overactive estrogen receptors, helping to slow disease progression.

The approval is based on the phase 3 EMBER-3 trial, in which 256 patients with ESR1-mutated metastatic breast cancer received Inluriyo or ET as first-line treatment following recurrence. Results showed that Inluriyo reduced the risk for progression or death by 38 percent versus ET. Inluriyo also significantly improved progression-free survival versus fulvestrant or exemestane, with a median progression-free survival of 5.5 months versus 3.8 months (hazard ratio, 0.62).

“This represents an important advancement for patients with ESR1-mutated metastatic breast cancer, a mutation found in nearly half of patients who have taken hormone therapies, often contributing to treatment resistance,” Komal Jhaveri, M.D., from the Memorial Sloan Kettering Cancer Center in New York City and a principal investigator of the EMBER-3 trial, said in a statement. “With its demonstrated efficacy, tolerability profile, and oral administration, this therapy provides a meaningful alternative treatment option for this patient population.”

Approval of Inluriyo was granted to Eli Lilly.

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