FDA approves Inluriyo plus Verzenio for ESR1-mutated advanced breast cancer
The FDA has approved Inluriyo in combination with Verzenio for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer following progression on endocrine therapy.
The combination pairs Lilly's oral selective estrogen receptor degrader imlunestrant with the CDK4/6 inhibitor abemaciclib for patients whose tumours carry an ESR1 mutation.
The approval also includes Guardant360 CDx as a companion diagnostic, reinforcing the role of circulating tumour DNA testing in identifying patients for biomarker-directed breast cancer treatment.
Field | Content |
Alert Type | Approval |
Drug Name | Imlunestrant |
Brand Name | Inluriyo |
Combination Therapy | Verzenio (abemaciclib) |
Company | Eli Lilly and Company |
Regulatory Authority | U.S. Food and Drug Administration |
Approval Type | Combination therapy approval |
Indication | Adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer following progression on at least one line of endocrine therapy |
Therapy Area(s) | Oncology; breast cancer |
Biomarker | ESR1 mutation |
Companion Diagnostic | Guardant360 CDx |
Technology or Modality | Oral selective estrogen receptor degrader plus CDK4/6 inhibitor |
Geography | United States |
What Happened | The FDA approved Inluriyo in combination with Verzenio for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after progression on endocrine therapy. |
Why It Matters | The approval introduces another biomarker-driven treatment option for patients whose cancers develop ESR1-mediated resistance to endocrine therapy. |
Supporting Context | ESR1 mutations are a recognised mechanism of acquired resistance in hormone receptor-positive breast cancer and can be detected using circulating tumour DNA testing. |
Key Takeaway | Inluriyo plus Verzenio is now an FDA-approved treatment option for ESR1-mutated advanced ER-positive, HER2-negative breast cancer. |
What to Watch | Clinical adoption of ESR1 testing, use of Guardant360 CDx and positioning of the combination within later-line endocrine treatment pathways. |
Primary Source | U.S. Food and Drug Administration |
Relevant Date | 18 September 2026 |
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