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  1. Medical Information Right
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  3. Inluriyo (imlunestrant) tablets Right
  4. Is expanded access/compassionate use available for Inluriyo™ (imlunestrant)?
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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 expanded access/compassionate use available for Inluriyo™ (imlunestrant)?

Since imlunestrant is now commercially available in the United States, there is no expanded access.

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US_cFAQ_IML002_EAPen-US

Imlunestrant Expanded Access Program (EAP)

Imlunestrant, an estrogen receptor antagonist, is approved by the US Food and Drug Administration for the 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

Expanded Access is a provision for acquiring treatment with an investigational drug until that drug is commercially available for any indication. Since imlunestrant is now commercially available in the United States, there is no expanded access.2

Eli Lilly and Company (Lilly) encourages patients to participate in clinical trials whenever possible. Participation in clinical trials allows patients to contribute to our understanding of a compound while helping Lilly to obtain the data necessary to advance the clinical development of the compound. Patients and their physicians can review ongoing and planned studies for imlunestrant by visiting https://trials.lilly.com/ or www.clinicaltrials.gov.

Enclosed Prescribing Information

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

References

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

2Expanded Access. Eli Lilly and Company. Accessed October 7, 2025. https://www.lilly.com/clinical-research/expanded-access

Date of Last Review: October 07, 2025

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