Eli Lilly Receives Full FDA Approval for Inluriyo + Verzenio to Treat ESR1-mutated Breast Cancer
Shots:
- FDA has granted full approval to Inluriyo (imlunestrant; PO) + Verzenio (abemaciclib) for treating adults with ER+, HER2-, ESR1-mutated locally advanced or metastatic breast cancer whose disease progressed after ≥1L of endocrine therapy (ET)
- Approval was based on the P-III (EMBER-3) trial assessing Inluriyo ± Verzenio in ESR1-mutated MBC pts (n=159); Inluriyo + Verzenio (n=67) doubled the mPFS vs Inluriyo alone (mPFS: 11.1 vs 5.5mos.)
- Inluriyo is also being studied in the P-III (EMBER-4) trial as an adj. therapy for ER+, HER2– early breast cancer at increased risk of recurrence following SoC ET, with initial results anticipated in 2027
Ref: PRnewswire | Image: Eli Lilly | Press Release
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