INDIANAPOLIS (dpa-AFX) - Eli Lilly and Company (LLY) announced that the U.S. Food and Drug Administration has granted full approval to Inluriyo (imlunestrant), an oral estrogen receptor (ER) antagonist, for use in combination with Verzenio (abemaciclib), a CDK4/6 inhibitor. The treatment is approved for adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer, as identified by an FDA-authorized test, whose disease has progressed following at least one line of endocrine therapy.
This marks the second FDA 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 (ET).
Inluriyo is also being studied in the Phase 3 EMBER-4 trial in the adjuvant setting for people with ER+, HER2- early-stage breast cancer (EBC) at increased risk of recurrence following standard of care endocrine therapy, including CDK4/6 inhibitors. EMBER-4 is the largest adjuvant oral SERD clinical trial, with more than 8,000 patients enrolled worldwide across 650+ sites in 30+ countries. Initial results are anticipated in 2027.
Inluriyo in combination with Verzenio is now available in the United States, the company said.
LLY closed Friday's regular trading at $1,152.93 up $0.49 or 0.04%.
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