HQ Team
September 21, 2026: The US Food and Drug Administration has approved a combination oral drug from Eli Lilly and Company to treat people with a type of breast cancer that has worsened after at least one hormone treatment.
The drug Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) treats patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1–mutated locally advanced or metastatic breast cancer.
The approval was based on results from an end-of-phase trial on 159 patients with tumour mutation. Patients who took both drugs went a median of 11.1 months before their cancer worsened, compared with 5.5 months for those who took Inluriyo alone.
“We have an urgent need for effective and safe treatment options for patients with disease progression on adjuvant or first-line therapy,” said Komal Jhaveri, MD, FACP, FASCO, and principal investigator for the trials.
Mutation
“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,” she said.
About half of the patients with ER-positive, HER2-negative metastatic breast cancer develop an ESR1 mutation during or after treatment with a widely used class of hormone-blocking therapies, according to a statement from Eli Lilly.
This is the second regulatory approval 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, according to the company statement.
Early treatment
Inluriyo is currently being studied as an adjuvant treatment in early breast cancer. Initial results are anticipated in 2027.
Metastatic or advanced breast cancer is defined as breast cancer that has spread from the breast to other parts of the body. Locally advanced breast cancer has grown beyond the breast to nearby tissue or lymph nodes, but has not spread to other parts of the body.
Of all high-risk early-stage breast cancer cases diagnosed in the US, approximately 30% will become metastatic and an estimated 6-10% are metastatic at diagnosis.
Survival is lower among patients with a more advanced disease at diagnosis. The estimated five-year survival rates for people living with breast cancer are 99% for localised disease, 86% for regional and locally advanced disease, and 30% for metastatic or advanced disease.
Other factors, such as tumour size, also impact five-year survival estimates.
