Imlunestrant: First Approval

Guglielmi G, Del Re M, Gol LS, et al. Pharmacological insights on novel oral selective estrogen receptor degraders in breast cancer. Eur J Pharmacol. 2024;969:176424.

Article  CAS  PubMed  Google Scholar 

Alva-Bianchi M, Sánchez-Bayona R, Ciruelos E. Oral SERDs: transforming the treatment of advanced breast cancer. Insights from EMBER-3. Medicina (Kaunas). 2025;6(2):100602.

CAS  Google Scholar 

Gheysen M, Punie K, Wildiers H, et al. Oral SERDs changing the scenery in hormone receptor positive breast cancer, a comprehensive review. Cancer Treat Rev. 2024;130:102825.

Article  CAS  PubMed  Google Scholar 

Pathak N, Oliveira M. New oral selective estrogen receptor degraders redefine management of estrogen receptor-positive breast cancer. Annu Rev Med. 2025;76(1):243–55.

Article  CAS  PubMed  Google Scholar 

Bhagwat SV, Mur C, Vandekopple M, et al. Imlunestrant is an oral, brain-penetrant selective estrogen receptor degrader with potent antitumor activity in ESR1 wild-type and mutant breast cancer. Cancer Res. 2025;85(4):777–90.

Article  CAS  PubMed  Google Scholar 

Brett JO, Spring LM, Bardia A, et al. ESR1 mutation as an emerging clinical biomarker in metastatic hormone receptor-positive breast cancer. Breast Cancer Res. 2021;23(1):85.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Kinslow CJ, Tang A, Chaudhary KR, et al. Prevalence of estrogen receptor alpha (ESR1) somatic mutations in breast cancer. JNCI Cancer Spectr. 2022. https://doi.org/10.1093/jncics/pkac060.

Article  PubMed  PubMed Central  Google Scholar 

Eli Lilly and Company. Imlunestrant: US prescribing information. 2025. https://inluriyo.lilly.com/. Accessed 23 Oct 2025.

Eli Lilly and Company. U.S. FDA approves Inluriyo (imlunestrant) for adults with ER+, HER2−, ESR1-mutated advanced or metastatic breast cancer [media release]. 25 Sep 2025. https://investor.lilly.com/.

US Food and Drug Administration. FDA approves imlunestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer [media release]. 25 Sep 2025. https://www.fda.gov/.

Sherman S, Sandusky ZM, Russo D, et al. Imlunestrant a next-generation oral SERD overcomes ESR1 mutant resistance in estrogen receptor-positive breast cancer. JCI Insight. 2025. https://doi.org/10.1172/jci.insight.188051.

Article  PubMed  PubMed Central  Google Scholar 

Neven P, Stahl N, Vidal M, et al. A preoperative window-of-opportunity study of oral SERD, imlunestrant, in newly diagnosed ER-positive, HER2-negative early breast cancer: results from the EMBER-2 study. Clin Cancer Res. 2024;30(23):5304–13.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Jhaveri KL, Lim E, Jeselsohn R, et al. Imlunestrant, an oral selective estrogen receptor degrader, as monotherapy and in combination with targeted therapy in estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: phase Ia/Ib EMBER study. J Clin Oncol. 2024;42(35):4173–86.

Article  CAS  PubMed  Google Scholar 

Jhaveri KL, Neven P, Casalnuovo ML, et al. Imlunestrant with or without abemaciclib in advanced breast cancer. N Engl J Med. 2025;392(12):1189–202.

Article  CAS  PubMed  Google Scholar 

Yonemori K, Boni V, Min KG, et al. Imlunestrant, an oral selective estrogen receptor degrader, as monotherapy and combined with abemaciclib, in recurrent/advanced ER-positive endometrioid endometrial cancer: results from the phase 1a/1b EMBER study. Gynecol Oncol. 2024;191:172–81.

Article  CAS  PubMed  Google Scholar 

Zhang J, Zhu Y, Liang H, et al. Imlunestrant, a novel orally bioavailable selective estrogen receptor degrader (SERD) in Chinese patients with ER positive (ER+), human epidermal growth factor receptor 2 negative (HER2−) locally advanced or metastatic breast cancer (mBC): results from a phase 1 study [abstract no. CT027]. Cancer Res. 2025;85(8 Suppl 2).

Guardant. FDA approves Guardant360® CDx as companion diagnostic for Eli Lilly and Company’s Inluriyo™ (imlunestrant) for treatment of ESR1-mutated advanced breast cancer [media release]. 29 Sep 2025. https://investors.guardanthealth.com/.

Jhaveri K, O’Shaughnessy J, Andre F, et al. 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 [abstract no. OT1-01-02]. Cancer Res. 2023;83(5 Suppl).

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