礼来宣布Inluriyo（伊曲替尼）与Verzenio（阿贝马西替尼）联合用于治疗成人雌激素受体阳性、HER2阴性、ESR1突变的晚期或转移性乳腺癌患者已获FDA批准

INDIANAPOLIS, Sept. 18, 2026 /PRNewswire/ --Eli Lilly and Company(NYSE: LLY) announced today that the U.S. Food and Drug Administration(FDA) has granted full approval to Inluriyo (imlunestrant), an oral estrogen receptor (ER) antagonist, in combination with Verzenio (abemaciclib), a CDK4/6 inhibitor, for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated locally advanced or metastatic breast cancer (MBC), as detected by anFDA-authorized test, with disease progression following at least one line of endocrine therapy. The approval is based on the proven clinical benefit of switching to Inluriyo in combination with Verzenio at clinical progression as observed in the Phase 3 EMBER-3 trial.

"In less than a year since its approval, Inluriyo is the leading treatment option for people with ER+, HER2–, ESR1m metastatic breast cancer, now reaching over half of all patients starting an oral SERD," saidJacob Van Naarden, executive vice president and president ofLillyOncology. "Today's full approval extends what Inluriyo in combination with Verzenio can do for patients, with a regimen that has confirmed benefit, is aligned to the clinically proven treatment paradigm of changing therapy at clinical progression, and doesn't introduce burdensome monitoring requirements for patients or physicians. In fact, all available evidence suggests that switching endocrine therapy and CDK4/6 inhibitor at clinical progression improves patient outcomes more than switching therapy earlier. Utilizing this evidence-based practice spares early exposure to additional side effects, reduces patient anxiety from unnecessary testing, and mitigates avoidable costs to the healthcare system."

This fullFDAapproval is based on the results of the Phase 3 EMBER-3 trial in patients with MBC whose tumors harbor an ESR1 mutation (n=159). Patients received Inluriyo (n=92) or Inluriyo in combination with Verzenio (n=67) after an aromatase inhibitor (AI), with or without a CDK4/6 inhibitor, in either the adjuvant or metastatic setting. Among patients with ESR1-mutated MBC, Inluriyo in combination with Verzenio doubled median progression-free survival (PFS) versus Inluriyo alone, with a median PFS of 11.1 months versus 5.5 months (HR=0.53 [95% CI, 0.35–0.80]).

"We have an urgent need for effective and safe treatment options for patients with disease progression on adjuvant or first-line therapy. Combining therapies that work on two distinct drivers of tumor growth—the estrogen receptor and CDK4/6—is an important strategy to help address treatment resistance," saidKomal Jhaveri, MD, FACP, FASCO, Associate Attending Breast Medicine and Early Drug Development Services, section head of the Endocrine Therapy Research Program at Memorial Sloan Kettering Cancer Center, and principal investigator for the EMBER-3 and EMBER-4 trials. "In EMBER-3, switching both the endocrine therapy and CDK 4/6 inhibitor, for the majority of patients, to imlunestrant plus abemaciclib at disease progression achieved a median progression-free survival of 11.1 months and a safety profile consistent with that of each medicine individually, establishing a meaningful new treatment option."

In about half of patients with ER+, HER2– MBC, tumors develop a genetic change called an ESR1 mutation during or after treatment with a common class of hormone-blocking medicines known as AIs. These mutations can cause estrogen receptors to become overactive, fueling cancer growth. Inluriyo and Verzenio target two different drivers of tumor growth, offering a combined approach to help slow the disease. Inluriyo degrades mutated estrogen receptors, cutting off the signal that drives cancer cells to grow. Verzenio targets proteins that control how quickly cancer cells divide, helping to slow their growth.

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 Verzenio label contains warnings and precautions for severe diarrhea, neutropenia, interstitial lung disease/pneumonitis, hepatotoxicity, venous thromboembolism, embryo-fetal toxicity, and increased serum creatinine without affecting renal function. See Important Safety Information below and full Prescribing Information for additional information.

In EMBER-3, the majority of adverse events (AEs) with Inluriyo in combination with Verzenio were Grade 1-2. The most common (≥10%) adverse reactions, including laboratory abnormalities, were decreased neutrophils, diarrhea, decreased hemoglobin, decreased lymphocytes, nausea, decreased platelets, fatigue, increased triglycerides, infections, increased AST, increased creatinine, increased ALT, vomiting, musculoskeletal pain, abdominal pain, decreased appetite, increased cholesterol, rash, cough, headache, and decreased weight. Permanent discontinuation of Inluriyo alone due to adverse reactions in the combination arm occurred in 1% of patients, and permanent discontinuation of Verzenio alone in the combination arm occurred in 3.4% of patients.

This marks the secondFDAapproval for Inluriyo in less than a year, following its September 2025 approval as monotherapy for the treatment of adults with ER+, HER2–, ESR1-mutated MBC whose disease progressed after at least one line of endocrine therapy (ET).

Inluriyo is also being studied in the Phase 3 EMBER-4 trial (NCT05514054) in the adjuvant setting for people with ER+, HER2– early-stage breast cancer (EBC) at increased risk of recurrence following standard of care endocrine therapy, including CDK4/6 inhibitors. EMBER-4 is the largest adjuvant oral SERD clinical trial, with more than 8,000 patients enrolled worldwide across 650+ sites in 30+ countries. Initial results are anticipated in 2027.

Inluriyo in combination with Verzenio is now available inthe United States.

See Important Safety Information below and full Prescribing Information for additional information.

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 September 2026.

4. American Cancer Society. Breast Cancer Facts & Figures 2022-2024. Atlanta: American Cancer Society, Inc. 2022. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/breast-cancer-facts-and-figures/2022-2024-breast-cancer-fact-figures-acs.pdf. Accessed September 2026.

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 September 2026.