U.S. FDA approves Inluriyo (imlunestrant) for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer
Eli Lilly (NYSE:LLY) has received FDA approval for Inluriyo (imlunestrant), an oral estrogen receptor antagonist for treating adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer who progressed after endocrine therapy.
In the Phase 3 EMBER-3 trial, Inluriyo demonstrated significant efficacy by reducing progression or death risk by 38% versus endocrine therapy. The median progression-free survival was 5.5 months compared to 3.8 months for standard treatment. The drug showed a manageable safety profile with mostly Grade 1-2 adverse events.
Inluriyo targets ESR1 mutations, which occur in approximately 50% of patients who have taken hormone therapies. The drug will be available in the U.S. within weeks and is currently being studied in the Phase 3 EMBER-4 trial for early breast cancer treatment.
Eli Lilly (NYSE:LLY) ha ottenuto l'approvazione da parte della FDA per Inluriyo (imlunestrant), un antagonista orale del recettore degli estrogeni per il trattamento di adulti con cancro al seno avanzato o metastatico ER+, HER2-, con mutazione ESR1 che si è progressivamente evoluto dopo terapie ormonali.
Nello studio di fase 3 EMBER-3, Inluriyo ha mostrato una significativa efficacia riducendo il rischio di progresso o morte del 38%. La sopravvivenza libera da progressione mediana è stata di 5,5 mesi contro 3,8 mesi per il trattamento standard. Il profilo di sicurezza è stato gestibile, con principalmente eventi avversi di grado 1-2.
Inluriyo mira le mutazioni ESR1, che si verificano in circa 50% dei pazienti che hanno ricevuto terapie ormonali. Il farmaco sarà disponibile negli Stati Uniti entro poche settimane e attualmente è oggetto di studio nello studio di fase 3 EMBER-4 per il trattamento del cancro al seno in stadio precoce.
Eli Lilly (NYSE:LLY) ha recibido la aprobación de la FDA para Inluriyo (imlunestrant), un antagonista oral del receptor de estrógenos para el tratamiento de adultos con cáncer de mama avanzado o metastásico ER+, HER2-, con mutación ESR1 que progresó tras la terapia hormonal.
En el ensayo EMBER-3 de fase 3, Inluriyo demostró una eficacia significativa al reducir el riesgo de progresión o muerte en un 38%. La mediana de supervivencia libre de progresión fue de 5,5 meses frente a 3,8 meses para el tratamiento estándar. El perfil de seguridad fue manejable, con principalmente eventos adversos de grado 1-2.
Inluriyo apunta a las mutaciones ESR1, que ocurren en aproximadamente el 50% de los pacientes que han recibido terapias hormonales. El fármaco estará disponible en los EE. UU. en unas semanas y se está estudiando actualmente en el ensayo de fase 3 EMBER-4 para el tratamiento del cáncer de seno en etapas precoces.
Eli Lilly (NYSE:LLY)는 Inluriyo(임lunestrant)의 FDA 승인을 받았으며, 이는 호르몬 치료를 받은 후 진행된 ER+ HER2- ESR1 돌연변이 양성의 진행성 또는 전이성 유방암을 치료하기 위한 경구용 에스트로겐 수용체 길항제이다.
3상 EMBER-3 연구에서 Inluriyo는 중추적한 효과를 보여 호르몬 치료 대비 진행 위험 또는 사망 위험을 38% 줄였다. 중간 무진행 생존 기간은 5.5개월으로 표준 치료의 3.8개월에 비해 증가했다. 약물의 안전성 프로파일은 주로 1-2등급의 부작용으로 관리 가능했다.
Inluriyo는 ESR1 돌연변이를 타깃으로 하며, 이는 호르몬 치료를 받은 환자의 약 50%에서 발생한다. 이 약은 몇 주 내에 미국에서 이용 가능해질 것이며, 현재 3상 EMBER-4 연구에서도 초기 유방암 치료를 대상으로 연구 중이다.
Eli Lilly (NYSE:LLY) a obtenu l’approbation de la FDA pour Inluriyo (imlunestrant), un antagoniste oral du récepteur des œstrogènes destiné au traitement des adultes atteints d’un cancer du sein avancé ou métastatique ER+, HER2-, avec mutation ESR1 qui a progressé après une thérapie endocrinienne.
Dans l’essai de phase 3 EMBER-3, Inluriyo a démontré une efficacité significative en réduisant le risque de progression ou de décès de 38%. La médiane de survie sans progression était de 5,5 mois contre 3,8 mois pour le traitement standard. Le profil de sécurité était gérable avec principalement des événements indésirables de grade 1-2.
Inluriyo cible les mutations ESR1, qui surviennent chez environ 50% des patients ayant reçu des thérapies hormonales. Le médicament sera disponible aux États-Unis dans les prochaines semaines et est actuellement étudié dans l’essai de phase 3 EMBER-4 pour le traitement du cancer du sein en phase précoce.
Eli Lilly (NYSE:LLY) hat die FDA-Zulassung für Inluriyo (Imlunestrant) erhalten, einen oralen Antagonisten des Östrogenrezeptors zur Behandlung von Erwachsenen mit ER+, HER2-, ESR1-mutiertem fortgeschrittenem oder metastasiertem Brustkrebs, der nach einer endokrinen Therapie fortgekommen ist.
In der Phase-3-Studie EMBER-3 zeigte Inluriyo eine signifikante Wirksamkeit, indem das Risiko für Fortschreiten oder Tod um 38% reduziert wurde. Das mediane progressionsfreie Überleben betrug 5,5 Monate gegenüber 3,8 Monaten bei der Standardbehandlung. Das Sicherheitsprofil war gut beherrschbar, überwiegend mit Grad-1-2-Nebenwirkungen.
Inluriyo zielt auf ESR1-Mutationen ab, die bei etwa 50% der Patientinnen auftreten, die eine Hormontherapie erhalten haben. Das Medikament wird in den USA innerhalb weniger Wochen verfügbar sein und wird derzeit in der Phase-3-Studie EMBER-4 zur Behandlung von frühem Brustkrebs untersucht.
إيلي ليلي (رمز التداول في بورصة نيويورك: LLY) حصلت على موافقة FDA لInluriyo (imlunestrant)، وهو مضاد مستقبلات الإستروجين عن طريق الفم لعلاج البالغين المصابين بـسرطان الثدي المتقدم أو النقيلة ER+،HER2-، مع طفرة ESR1 التي تطورت بعد العلاج بالهرمونات.
في تجربة EMBER-3 من المرحلة الثالثة، أظهر Inluriyo فاعلية كبيرة من خلال تقليل مخاطر التقدم أو الوفاة بنسبة 38%. بلغ متوسط البقاء دون تقدم المرض 5.5 أشهر مقابل 3.8 أشهر للعلاج القياسي. كان الملف الأمني قابلًا للإدارة مع أحداث جانبية من الدرجة 1-2 بشكل رئيسي.
يستهدف Inluriyo طفرات ESR1، التي تحدث في نحو 50% من المرضى الذين تلقوا علاجات هرمونية. سيتوفر الدواء في الولايات المتحدة خلال أسابيع ويناقش حاليًا في تجربة EMBER-4 من المرحلة الثالثة لعلاج سرطان الثدي في المراحل المبكرة.
礼来制药（NYSE:LLY） 已获得 FDA 对 Inluriyo（imlunestrant） 的批准，这是一种口服雌激素受体拮抗剂，用于治疗经内分泌治疗后进展的成人患者，患有 ER+、HER2-、 ESR1 突变的晚期或转移性乳腺癌。
在 III 期 EMBER-3 试验中，Inluriyo 显示出显著疗效，相比内分泌治疗，进展或死亡风险降低了 38%。中位无进展生存期为 5.5 个月，而标准治疗为 3.8 个月。药物安全性可控，主要的不良事件为 1-2 级。
Inluriyo 针对 ESR1 突变，这在接受激素治疗的患者中大约占 50%。该药将在数周内在美国上市，目前在 III 期 EMBER-4 试验中研究早期乳腺癌的治疗。
- FDA approval received for novel oral breast cancer treatment Inluriyo
- Significant 38% reduction in risk of progression or death versus endocrine therapy
- Improved progression-free survival of 5.5 months vs 3.8 months (HR=0.62)
- Favorable safety profile with low discontinuation rate of 4.6%
- Convenient once-daily oral administration
- Limited progression-free survival benefit of 1.7 months
- Potential side effects including decreased hemoglobin, musculoskeletal pain, and laboratory abnormalities
- Carries warning for embryo-fetal toxicity
Insights
FDA approval of Inluriyo for ESR1-mutated breast cancer represents significant advancement with 38% reduced progression risk versus standard therapy.
The FDA approval of Inluriyo (imlunestrant) marks a significant therapeutic advancement for patients with ER+, HER2-, ESR1-mutated metastatic breast cancer. This oral estrogen receptor antagonist demonstrated a 38% reduction in the risk of disease progression or death compared to standard endocrine therapy in the Phase 3 EMBER-3 trial.
The clinical significance is substantial - Inluriyo achieved a median progression-free survival of 5.5 months versus 3.8 months with standard therapy (HR=0.62), with statistical significance (p=0.0008). This improvement addresses a critical unmet need in treating hormone-resistant breast cancer, as approximately 50% of ER+, HER2- metastatic patients develop ESR1 mutations following aromatase inhibitor treatment.
Mechanistically, Inluriyo works by binding to, blocking, and facilitating the degradation of estrogen receptors that have become constitutively active due to ESR1 mutations. This mechanism directly targets the molecular driver of resistance in these patients.
The safety profile appears manageable, with primarily low-grade adverse events. Only 4.6% of patients discontinued treatment due to adverse events, with dose adjustments needed in a minority of patients (2.4% reductions, 10% interruptions). The once-daily oral administration offers practical advantages over injectable therapies like fulvestrant.
The ongoing EMBER-4 trial investigating Inluriyo in the adjuvant setting for early breast cancer signals potential expansion to earlier disease stages, which could substantially increase the drug's clinical impact and market potential if successful.
This FDA approval represents a strategic win for Eli Lilly in the competitive oncology market. Inluriyo addresses a precise molecular subset of breast cancer patients - those with ESR1 mutations who have developed resistance to standard endocrine therapies. This positioning as a targeted therapy for a specific resistance mechanism demonstrates Lilly's execution of the industry-wide shift toward precision medicine.
The once-daily oral administration gives Inluriyo a significant competitive advantage over injectable therapies like fulvestrant in the treatment landscape. For patients with metastatic disease requiring long-term treatment, the convenience of oral therapy can substantially impact quality of life and potentially improve adherence.
The timing of this approval is noteworthy, as Lilly is simultaneously conducting the larger EMBER-4 trial in the adjuvant setting, which could eventually expand Inluriyo's market by moving it into earlier treatment lines where patient populations are larger and treatment durations longer. This strategic sequencing of approvals from metastatic to early disease settings follows a well-established pathway for maximizing a drug's commercial potential.
While the press release doesn't mention pricing, targeted therapies for precision oncology indications typically command premium pricing, particularly when they demonstrate efficacy in patients with limited treatment options. The specified launch timeline of "coming weeks" indicates Lilly's readiness for immediate commercialization, suggesting manufacturing and distribution channels are already established.
For investors, this approval strengthens Lilly's oncology portfolio and represents potential long-term revenue growth, especially if the adjuvant trial proves successful and leads to expanded indications.
An estimated
In the Phase 3 EMBER-3 trial, Inluriyo monotherapy reduced the risk of progression or death by
Inluriyo is a treatment for ER+, HER2–, ESR1-mutated MBC. Some breast cancers develop ESR1 mutations that can cause estrogen receptors to become overactive and drive cancer growth. Inluriyo binds, blocks, and facilitates the degradation of these receptors, helping to slow disease progression. Its once-daily dosing provides patients with an oral treatment option.
"This therapy reflects our commitment to developing treatments that improve outcomes for people with breast cancer and represents an important step toward advancing innovative, all-oral treatment approaches," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "We are deeply grateful to the patients, investigators, Lilly team members and clinical care teams who made this advancement possible. This therapy has the potential to make the treatment journey more manageable for those living with breast cancer."
The Inluriyo label contains a warning and precaution for embryo-fetal toxicity. See Important Safety Information below and full Prescribing Information for additional information.
The FDA approval is based on the results of the EMBER-3 trial in the patient population harboring ESR1-mutated MBC (n=256). Patients received Inluriyo or ET as first-line treatment for MBC following recurrence on adjuvant aromatase inhibitor (AI), +/- prior CDK4/6 inhibitor (
"This represents an important advancement for patients with ESR1-mutated MBC, a mutation found in nearly half of patients who have taken hormone therapies, often contributing to treatment resistance," said Komal Jhaveri, M.D., FACP, FASCO, section head of Endocrine Therapy Research and clinical director of Early Drug Development at Memorial Sloan Kettering Cancer Center, and a principal investigator of EMBER-3. "With its demonstrated efficacy, tolerability profile and oral administration, this therapy provides a meaningful alternative treatment option for this patient population."
In EMBER-3, the majority of adverse events (AEs) with Inluriyo were low grade (Grade 1-2) and the most common adverse reactions (≥
"The approval of Inluriyo expands the metastatic breast cancer treatment landscape for patients who test positive for the ESR1 mutation," said Jean Sachs, CEO, Living Beyond Breast Cancer. "Eligible patients will now have access to an additional treatment option, offering them the potential for flexibility in their daily lives and disease management, and—above all—renewed hope for the future."
Inluriyo is also being studied in the ongoing Phase 3 EMBER-4 trial in the adjuvant setting for people with ER+, HER2– early breast cancer (EBC) at increased risk of recurrence, which is enrolling approximately 8,000 patients worldwide.
Inluriyo is expected to be available in
See Important Safety Information below and full Prescribing Information for additional information.
About EMBER-3
EMBER-3 is a Phase 3, randomized, open-label study of Inluriyo, investigator's choice of endocrine therapy, and Inluriyo in combination with abemaciclib in patients with ER+, 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 CDK 4/6 inhibitor. The trial enrolled 874 adult patients,
About Inluriyo (imlunestrant)
Inluriyo (imlunestrant) (pronounced en-loo-ree-yoh) is an oral estrogen receptor antagonist that delivers continuous ER inhibition, including in ESR1-mutant cancers. The estrogen receptor (ER) is the key therapeutic target for patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–) breast cancer. Inluriyo is a
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
Most Common Adverse Reactions
The most common adverse reactions (incidence ≥
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.
IN HCP ISI M APP
About Metastatic/Advanced Breast Cancer
Metastatic/advanced breast cancer (MBC) is a cancer that has spread from the breast tissue to other parts of the body. Locally advanced breast cancer means the cancer has grown outside the organ where it started but has not yet spread to other parts of the body.1 Of all high risk early-stage breast cancer cases diagnosed in the
About Breast Cancer
Breast cancer is the second most commonly diagnosed cancer worldwide (following lung cancer), according to GLOBOCAN. The estimated 2.3 million new cases indicate that close to 1 in every 4 cancers diagnosed in 2022 is breast cancer. With approximately 666,000 deaths in 2022, breast cancer is the fourth-leading cause of cancer death worldwide.5 In the
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY
PP-IN-US-0139 09/2025
© Lilly USA, LLC 2025. ALL RIGHTS RESERVED.
MSK Disclosure: Dr. Jhaveri has financial interests related to Eli Lilly and Company.
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All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Inluriyo as a treatment for people with certain types of breast cancer and other conditions and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that Inluriyo will receive additional regulatory approvals, or that Inluriyo will be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
Endnotes & References
1. André F, et al. Ann Oncol. 2021;32(2):208-217.
2. O'Shaughnessy J. Extending survival with chemotherapy in metastatic breast cancer. Oncologist. 2005;10 Suppl 3:20-9. PMID: 16368868 DOI: 10.1634/theoncologist.10-90003-20.
3. Metastatic Breast Cancer Network. 13 Facts about Metastatic Breast Cancer. http://www.mbcn.org/13-facts-about-metastatic-breast-cancer/. Accessed July 9, 2024.
4. American Cancer Society. Breast Cancer Facts & Figures 2022-2024.
5. Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263.
6. American Cancer Society. Cancer Statistics Center. http://cancerstatisticscenter.cancer.org. Accessed July 9, 2024.
Refer to: | Michelle Webb; michelle.webb@lilly.com; 463-206-4463 (Media) | |
Michael Czapar; czapar_michael_c_@lilly.com; 317-617-0983 (Investors) |
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