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  1. Medical Information Right
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  3. Inluriyo (imlunestrant) tablets Right
  4. Is Inluriyo™ (imlunestrant) FDA approved?
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Inluriyo ™ (imlunestrant) tablets

200 mg

Full Prescribing Information

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

Is Inluriyo™ (imlunestrant) FDA approved?

Inluriyo (imlunestrant) was approved by the Food and Drug Administration (FDA) on September 25, 2025.

US_cFAQ_IML803_FDA_APPROVAL
US_cFAQ_IML803_FDA_APPROVALen-US

FDA Approval and Indication

Imlunestrant is an estrogen receptor antagonist indicated for treatment of adults with 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.1

Additional Information

More detailed information can be found on the U.S. Food and Drug Administration website: www.fda.gov 

Enclosed Prescribing Information

INLURIYO™ (imlunestrant) tablets, for oral use, Lilly

Enclosed Patient Information

INLURIYO™ (imlunestrant) patient information, Lilly

Reference

1Inluriyo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.

Date of Last Review: September 25, 2025

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