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Is there expanded access/compassionate use available for imlunestrant?
As multiple treatment options are available, imlunestrant does not meet the criteria for expanded access or compassionate use at this time.
Imlunestrant Expanded Access Program (EAP)
Imlunestrant (LY3484356) is a chemical entity that functions as an oral selective estrogen receptor degrader (SERD). It is being studied by Eli Lilly and Company (Lilly) for
- second-line treatment of estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer as monotherapy and in combination with abemaciclib, and
- treatment of ER+, HER2- early breast cancer.1
Currently, imlunestrant is investigational and is not under review with any regulatory authorities across the globe.1
Lilly may consider providing investigational medicine outside of a clinical trial. This is called expanded access or compassionate use. Lilly supports requests for expanded access that meet the criteria defined on the Lilly Expanded Access website.2
Expanded access may be an option for a limited number of individuals with serious or life-threatening conditions who
- have exhausted all available medical options (ie, no comparable or satisfactory alternative therapies exist)
- are ineligible for clinical trials, and
- meet all additional requirements for the EAP.2
As there are other SERDs approved by the Food and Drug Administration, European Medicines Agency, and other global regulatory agencies, imlunestrant does not meet the criteria for the provision of expanded access.
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.2
Access to imlunestrant at this time is only available through currently enrolling clinical trials.
1Clinical Development Pipeline. Eli Lilly and Company. Accessed September 12, 2023. https://www.lilly.com/discovery/clinical-development-pipeline
2Expanded Access. Eli Lilly and Company. Accessed September 12, 2023. https://www.lilly.com/clinical-research/expanded-access
Date of Last Review: September 12, 2023