Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has granted full approval for Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for adults with estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer. The treatment is intended for patients whose disease has progressed following at least one line of endocrine therapy and whose ESR1 mutation is confirmed through an FDA-authorised test.
The approval is based on findings from the Phase 3 EMBER-3 trial, which evaluated patients with ESR1-mutated metastatic breast cancer following treatment with an aromatase inhibitor, with or without a CDK4/6 inhibitor. In this patient group, the combination achieved a median progression-free survival of 11.1 months, compared with 5.5 months for Inluriyo alone.
Inluriyo is an oral estrogen receptor antagonist designed to target and degrade estrogen receptors, while Verzenio is a CDK4/6 inhibitor that targets proteins involved in cancer-cell division. The combination is intended to address two pathways involved in the growth of ER-positive breast cancer.
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“In less than a year since its approval, Inluriyo is the leading treatment option for people with ER+, HER2–, ESR1m metastatic breast cancer, now reaching over half of all patients starting an oral SERD.” said Jacob Van Naarden, executive vice president and president of Lilly Oncology.
The safety findings from EMBER-3 were generally consistent with the established profiles of the two medicines, with most adverse events reported as Grade 1 or 2. Frequently reported reactions included decreased blood-cell counts, diarrhoea, nausea, fatigue, infections, vomiting and musculoskeletal pain.
“We have an urgent need for effective and safe treatment options for patients with disease progression on adjuvant or first-line therapy. 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,” said Komal Jhaveri, MD, FACP, FASCO, Associate Attending Breast Medicine and Early Drug Development Services, section head of the Endocrine Therapy Research Program at Memorial Sloan Kettering Cancer Center, and principal investigator for the EMBER-3 and EMBER-4 trials. “In EMBER-3, switching both the endocrine therapy and CDK 4/6 inhibitor, for the majority of patients, to imlunestrant plus abemaciclib at disease progression achieved a median progression-free survival of 11.1 months and a safety profile consistent with that of each medicine individually, establishing a meaningful new treatment option.”
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The FDA decision marks the second approval for Inluriyo in the US, following its 2025 approval as a monotherapy for adults with ER+, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after progression on endocrine therapy.
Inluriyo is also being evaluated in the Phase 3 EMBER-4 trial for people with ER+, HER2-negative early-stage breast cancer who have an increased risk of recurrence. Initial results from the study are expected in 2027.
