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FDA Medication Tracker

← All approvals · Cancer · 2025

Inluriyo (imlunestrant)

The FDA approved Inluriyo (imlunestrant) on September 25, 2025 to treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, estrogen receptor-1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
Brand name
Inluriyo
Generic name
imlunestrant
FDA approval date
September 25, 2025
Approved use (FDA wording)
To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, estrogen receptor-1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy
Category on this site
Cancer

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.