The FDA has approved a new oral combination therapy, Inluriyo and Verzenio, for patients with advanced or metastatic ER-positive, HER2-negative breast cancer carrying an ESR1 mutation.
Key facts
- •The FDA approved the Inluriyo and Verzenio combination on September 18.
- •The treatment is for patients with ER-positive, HER2-negative breast cancer and an ESR1 mutation.
- •In the EMBER-3 trial, the combination extended the median time before cancer progression to 11.1 months.
- •The FDA-authorized Guardant360 CDx blood test can identify the ESR1 mutation.
- •Verzenio was first approved in 2017, while Inluriyo received stand-alone approval in September 2025.
On September 18, the FDA approved a new all-oral combination treatment for adults with ER-positive, HER2-negative advanced or metastatic breast cancer that has an ESR1 gene mutation and has progressed after hormone therapy. The treatment pairs Inluriyo (imlunestrant) with Verzenio (abemaciclib), both manufactured by Eli Lilly and Company. This approval provides a new option for patients whose cancer has developed resistance to initial hormone therapies.
By the numbers
Clinical Trial Results and Efficacy
The approval is based on data from a cohort of 159 participants in the EMBER-3 clinical trial. Results showed that patients taking the combination therapy went a median of 11.1 months before their cancer grew or they died, compared to 5.5 months for those taking Inluriyo alone. Additionally, tumors shrank in 35% of patients receiving the combination, versus 15% for those on the single-drug regimen.
Mechanism and Administration
Inluriyo functions by blocking estrogen signals and breaking down the receptors that receive them, while Verzenio inhibits CDK4 and CDK6 proteins to slow cancer cell division. This oral combination replaces the need for older, injectable hormone therapies like fulvestrant. Patients can identify if they are candidates for this treatment through an FDA-authorized blood test, such as the Guardant360 CDx, which detects the presence of the ESR1 mutation.
Safety and Side Effects
The most common side effect associated with the combination is diarrhea, a known issue with Verzenio. According to clinical trial data, 86% of patients experienced diarrhea, with 9% reporting severe cases. Approximately 6% of patients discontinued treatment due to side effects. Patients are advised to manage symptoms with anti-diarrhea medication and increased fluid intake.
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This article was independently rewritten by ManyPress editorial AI from reporting originally published by Healthline.
