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) in patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer whose disease has recurred or progressed during or following an aromatase inhibitor (AI) therapy with or without a cyclin-depedent kinase 4 or 6 (CDK 4/6) inhibitor as monotherapy and in combination with abemaciclib.1

Currently, imlunestrant is investigational. A new drug application has been submitted to the United States Food and Drug Administration (FDA).2

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.3

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.3
  

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.3

Access to imlunestrant at this time is only available through currently enrolling clinical trials.