TUESDAY, Sept. 30, 2025 (HealthDay News) -- 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

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