Imlunestrant isindicated for the treatment of adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.[1][2]
Efficacy was evaluated in EMBER-3 (NCT04975308), a randomized, open-label, active-controlled, multi-center trial that enrolled 874 participants with ER-positive, HER2-negative locally advanced or metastatic breast cancer previously treated with an aromatase inhibitor either alone or in combination with a CDK4/6 inhibitor.[2] Participants were excluded if they were eligible to receive a PARP inhibitor.[2]
Participants were randomized 1:1:1 to imlunestrant, an investigator's choice of endocrine therapy (fulvestrant orexemestane), or an additional investigational combination regimen.[2] Randomization was stratified by previous treatment with a CDK4/6 inhibitor, presence of visceral metastasis, and geographic region.[2] ESR1 mutational status was determined by blood circulating tumor deoxyribonucleic acid (ctDNA) analysis using the Guardant360 CDx assay and was limited to specific ESR1 mutations in the ligand-binding domain.[2]
Imlunestrant was approved for medical use in the United States in September 2025.[2][3]
In November 2025, theCommittee for Medicinal Products for Human Use of theEuropean Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Inluriyo, intended for the treatment of adults with locally advanced or metastatic breast cancer with an activating ESR1-mutation.[4] The applicant for this medicinal product is Eli Lilly Nederland B.V.[4]
^ab"Inluriyo EPAR".European Medicines Agency (EMA). 14 November 2025. Retrieved9 December 2025. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^"International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 88".WHO Drug Information.36 (3). 2022.hdl:10665/363551.
Jhaveri, Komal L.; Jeselsohn, Rinath; Lim, Elgene; Hamilton, Erika P.; Yonemori, Kan; Beck, J. Thaddeus; et al. (June 2022). "A phase 1a/b trial of imlunestrant (LY3484356), an oral selective estrogen receptor degrader (SERD) in ER-positive (ER+) advanced breast cancer (aBC) and endometrial endometrioid cancer (EEC): Monotherapy results from EMBER".Journal of Clinical Oncology.40 (16_suppl): 1021.doi:10.1200/JCO.2022.40.16_suppl.1021.S2CID249445691.
Jhaveri, Komal; O'Shaughnessy, Joyce; Andre, Fabrice; Goetz, Matthew P.; Harbeck, Nadia; Martín, Miguel; et al. (March 2023). "Abstract OT1-01-02: EMBER-4: A phase 3 adjuvant trial of imlunestrant vs standard endocrine therapy (ET) in patients with ER+, HER2- early breast cancer (EBC) with an increased risk of recurrence who have previously received 2 to 5 years of adjuvant ET".Cancer Research.83 (5_Supplement): OT1–01–02-OT1-01–02.doi:10.1158/1538-7445.SABCS22-OT1-01-02.
Clinical trial numberNCT04975308 for "A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer (EMBER-3)" atClinicalTrials.gov
This article incorporates text from this source, which is in thepublic domain.