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# FDA Approves Lilly Combo for Metastatic Breast Cancer
- URL: https://www.fdaweb.com/fda-approves-lilly-combo-for-metastatic-breast-cancer-d5161802/
- Published: 2026-09-18T16:00:00.000Z
- Updated: 2026-09-23T16:16:38.000Z
- Author: David McFarland
- Tags: Drugs, Legacy-ID-D5161802, #Import 2026-09-20 15:24

FDA has granted Eli Lilly full approval for the combination use of Inluriyo (imlunestrant) with Verzenio (abemaciclib) in adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

Approval was based on data from the EMBER-3 (NCT04975308) study, a randomized, open-label, active-controlled, multicenter trial that enrolled 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 randomized 1:1:1 to imlunestrant, an investigator’s choice of endocrine therapy (fulvestrant or exemestane), or imlunestrant in combination with abemaciclib,” the [agency says](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-combination-abemaciclib-er-positive-her2-negative-esr1-mutated-advanced-or?ref=fdaweb.com). “The major efficacy outcome measure for the combination of imlunestrant with abemaciclib was investigator-assessed progression-free survival (PFS) according to RECIST v1.1 in the overall population, comparing imlunestrant plus abemaciclib to imlunestrant monotherapy. Other efficacy outcome measures included overall survival (OS) and investigator-assessed objective response rate (ORR).”

FDA says that in an “exploratory subgroup analysis in 159 patients with ESR1 mutated tumors for the combination, the PFS HR estimate was 0.53 (95% CI: 0.35, 0.80). Median PFS in patients with ESR1 mutated tumors was 11.1 months (95% CI: 7.4, 13.7) in the imlunestrant and abemaciclib arm and 5.5 months (95% CI: 3.8, 7.2) in the imlunestrant alone arm. ORR was 35% (95% CI: 22, 48) and 15% (95% CI: 7, 23) in the respective arms.”