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Indication

Inluriyo™ is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.1

Inluriyo (imlunestrant) monotherapy campaign image

Inluriyo significantly improved mPFS in patients with ER+, HER2– ESR1m MBC while maintaining an oral dosing routine1

5.5 months mPFS

with Inluriyo (n=138)

vs

3.8 months mPFS

with fulvestrant (n=111) or exemestane (n=6)

(HR=0.62 [95% CI: 0.46-0.82]); P=0.00081*

Inluriyo starburst

Give her a post-Al oral therapy that lets you pause progression while she stays in the moment.1

*One patient was randomized to Arm B and did not receive drug (fulvestrant).1

Imlunestrant (Inluriyo) is recommended by NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)2

Imlunestrant (Inluriyo) is an NCCN Category 2A recommended as a 1L or subsequent-line therapy option† for patients with ER+, HER2–, ESR1-mutated MBC2

Please see full NCCN Guidelines® for more information.

NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. To view the most recent and complete version of the guideline, go online to NCCN.org.

Category 2A is based upon lower-level evidence; there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate.2

†For disease progression during or after a prior line of AI with or without a CDK4/6i therapy in the adjuvant or metastatic setting.2

*One patient was randomized to Arm B and did not receive drug (fulvestrant).1

†For disease progression during or after a prior line of AI with or without a CDK4/6i therapy in the adjuvant or metastatic setting.2

1L=first line; AI=aromatase inhibitor; CDK4/6i=cyclin-dependent kinase 4 and 6 dual inhibitor; CI=confidence interval; ER+=estrogen receptor-positive; ESR1=estrogen receptor-1; ESR1m=estrogen receptor-1-mutated; HER2–=human epidermal growth factor receptor 2-negative; HR=hazard ratio; MBC=metastatic breast cancer; NCCN=National Comprehensive Cancer Network; mPFS=median progression-free survival.

References:

  1. Inluriyo. Prescribing Information. Lilly USA, LLC.
  2. Referenced with permission from NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V2.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed March 1, 2026. To view the most recent and complete version of the guideline, go online to https://www.nccn.org.

INDICATION

Inluriyo™ is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.1

IMPORTANT SAFETY INFORMATION FOR INLURIYO™ (imlunestrant)

Warnings and Precautions - Embryo-Fetal Toxicity

Based on findings in animals and its mechanism of action, Inluriyo can cause fetal harm when administered to a pregnant woman. In an animal reproduction study, oral administration of imlunestrant to pregnant rats during the period of organogenesis led to embryo-fetal mortality and structural abnormalities at maternal exposures that were below the human exposure at the recommended dose based on area under the curve (AUC). Avoid the use of imlunestrant in pregnant women. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Inluriyo and for 1 week after the last dose.

Serious and Fatal Adverse Reactions

Serious adverse reactions occurred in 10% of patients who received Inluriyo. Serious adverse reactions in >1% of patients included pleural effusion (1.2%). Fatal adverse reactions occurred in 1.8% of patients who received Inluriyo, including cardiac arrest, acute myocardial infarction, right ventricular failure, hypovolemic shock, and upper gastrointestinal hemorrhage (each 0.3%).

Most Common Adverse Reactions

The most common adverse reactions (incidence ≥10%), including laboratory abnormalities, in patients who received Inluriyo were: hemoglobin decreased (30%), musculoskeletal pain (30%), calcium decreased (26%), neutrophils decreased (26%), AST increased (25%), fatigue (23%), diarrhea (22%), ALT increased (21%), triglycerides increased (21%), nausea (17%), platelets decreased (16%), constipation (10%), cholesterol increased (10%), and abdominal pain (10%).

Drug Interactions

Imlunestrant is a CYP3A substrate. Avoid concomitant use of Inluriyo with strong CYP3A inhibitors. If concomitant use cannot be avoided, reduce the dosage of Inluriyo. Avoid concomitant use of Inluriyo with strong CYP3A inducers. If concomitant use cannot be avoided, increase the dosage of Inluriyo.

Imlunestrant inhibits both P-gp and BCRP. Avoid concomitant use unless otherwise recommended in the Prescribing Information for P-gp or BCRP substrates where minimal concentration changes may lead to serious adverse reactions.

Use in Specific Populations - Lactation

Because of the potential for serious adverse reactions in the breastfed child, advise lactating women to not breastfeed during treatment with Inluriyo and for 1 week after the last dose.

Use in Specific Populations - Hepatic Impairment

Reduce the dose of Inluriyo for patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment. No dosage adjustment is recommended for patients with mild hepatic impairment (Child-Pugh A).

Inluriyo (imlunestrant) is available as 200 mg tablets.

Please click to access Prescribing Information for Inluriyo.

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