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NewsThe FDA has approved the combination of imlunestrant (Inluriyo) and abemaciclib (Verzenio) for adults with hormone therapy-resistant, ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. The approval, backed by the phase 3 EMBER-3 trial, targets a tough-to-treat patient population and comes alongside a companion diagnostic assay to identify eligible patients.
The FDA has approved the combination of imlunestrant (Inluriyo) and abemaciclib (Verzenio), both from Eli Lilly & Co., for adults with hormone therapy-resistant, estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. The approval also covers the companion diagnostic assay (Guardant360 CDx) used to identify eligible patients.
The green light was based on results from the phase 3 EMBER-3 trial, which enrolled 874 patients randomized to imlunestrant alone, standard endocrine therapy (fulvestrant or exemestane), or the imlunestrant-plus-abemaciclib combination. The dual-target approach — hitting both the estrogen receptor and CDK4/6 pathways — is designed to overcome the resistance mechanisms that make this cancer so difficult to treat.
By the Numbers:
Why it matters: For patients whose disease has progressed on adjuvant or first-line therapy, treatment options are limited. This approval offers a new, targeted combination strategy that addresses two distinct drivers of tumor growth simultaneously, giving oncologists a meaningful new tool in the fight against endocrine therapy-resistant breast cancer.
