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U.S. FDA approves Inluriyo (imlunestrant) for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer
_↗ investor.lilly.com
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The U.S. Food and Drug Administration (FDA) has granted approval to Eli LillyCompany for Inluriyo (imlunestrant), an oral estrogen receptor antagonist, for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease has progressed after at least one line of endocrine therapy. and Company for Inluriyo (imlunestrant), an oral estrogen receptor antagonist, for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease has progressed after at least one line of endocrine therapy.

This approval is especially critical given that an estimated 50% of patients with ER+, HER2– MBC will develop an ESR1 mutation following exposure to aromatase inhibitors, which often drives treatment resistance by making estrogen receptors overactive.

Inluriyo works by binding, blocking, and facilitating the degradation of these mutant estrogen receptors to slow cancer progression, offering patients a convenient once-daily, all-oral treatment option.

The approval is based on the results of the Phase 3 EMBER-3 trial, which demonstrated that Inluriyo monotherapy significantly reduced the risk of progression or death by 38% compared to endocrine therapy among the ESR1-mutated population, achieving a median progression-free survival (PFS) of 5.5 months versus 3.8 months. While generally well-tolerated, with most adverse events being low grade, the label includes a Warning and Precaution for embryo-fetal toxicity, necessitating effective contraception for patients and their partners. Common adverse reactions include decreased hemoglobin, musculoskeletal pain, and decreased calcium. Lilly is committed to making Inluriyo available in the U.S. in the coming weeks and is continuing to investigate its potential in other settings, including the adjuvant treatment of early breast cancer in the ongoing EMBER-4 trial.

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