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News|Articles|September 18, 2026
FDA Approves Inluriyo Plus Verzenio for Certain Advanced Breast Cancers
Author(s)Quincy Attobrah
Fact checked by: CURE staff
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Key Takeaways
- Regulatory indication requires an FDA-authorized ESR1 test, with Guardant360 CDx approved to select candidates for imlunestrant plus abemaciclib.
- Phase 3 EMBER-3 enrolled 874 post–aromatase inhibitor ER+/HER2− advanced/metastatic patients, randomizing to imlunestrant, investigator’s choice endocrine therapy, or imlunestrant plus abemaciclib.
FDA approves Inluriyo plus Verzenio for adults with ESR1-mutated, ER-positive, HER2-negative advanced or metastatic breast cancer after endocrine therapy.
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The Food and Drug Administration (FDA) has approved Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer whose disease has progressed following at least one line of endocrine therapy.
The approval, announced Sept. 18, 2026, applies to patients whose ESR1 mutation is identified using an FDA-authorized test. The FDA also approved the Guardant360 CDx assay as a companion diagnostic to identify patients with ESR1-mutated breast cancer who may be eligible for the treatment combination.
Inluriyo and Verzenio are both manufactured by Eli Lilly and Company.
What the Approval Means for Patients
ESR1 mutations can develop in ER-positive breast cancer and can contribute to resistance to certain endocrine therapies. Testing for these mutations can help doctors identify treatment options for patients whose cancer has progressed after previous endocrine treatment.
The new approval is based on findings from the phase 3 EMBER-3 trial, which included 874 adults 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.
Patients were randomly assigned to receive Inluriyo alone, an investigator's choice of endocrine therapy or Inluriyo in combination with Verzenio.
Inluriyo Plus Verzenio Delayed Disease Progression
Among 159 patients with ESR1-mutated tumors included in an exploratory subgroup analysis, the combination of Inluriyo and Verzenio was associated with a longer period before the cancer progressed compared with Inluriyo alone.
Median progression-free survival was 11.1 months with Inluriyo plus Verzenio compared with 5.5 months with Inluriyo alone. The progression-free survival hazard ratio was 0.53 (95% CI, 0.35-0.80).
The objective response rate was 35% with the combination compared with 15% with Inluriyo alone.
At the time of the interim analysis, overall survival data remained immature, with 35% of deaths reported among patients with ESR1-mutated tumors.
The FDA noted that while progression-free survival was statistically significant for the combination compared with Inluriyo alone in the overall study population, the benefit was observed in the ESR1-mutated population.
Safety and Treatment
The recommended dose of Inluriyo is 400 milligrams taken orally once daily on an empty stomach, at least two hours before food or one hour after food. When used in combination with Inluriyo, the recommended dose of Verzenio is 150 milligrams taken twice daily, with or without food. Treatment continues until the cancer progresses or side effects become unacceptable.
Inluriyo's prescribing information includes a warning and precaution for embryo-fetal toxicity. Verzenio's prescribing information includes warnings and precautions for diarrhea, neutropenia, interstitial lung disease or pneumonitis, liver toxicity, venous thromboembolism and embryo-fetal toxicity.
For patients with ER-positive, HER2-negative advanced or metastatic breast cancer, the approval provides another treatment approach for disease with an ESR1 mutation following progression on endocrine therapy.
References
- U.S. Food and Drug Administration. “FDA Approves Imlunestrant in Combination With Abemaciclib for ER-Positive, HER2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer.” Sept. 18, 2026.
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