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# MONARCH 3 Results Show Verzenio Success: Lilly
- URL: https://www.fdaweb.com/monarch-3-results-show-verzenio-success-lilly/
- Published: 2023-12-05T12:00:00.000Z
- Updated: 2026-09-14T14:17:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155917

Lilly says results of the MONARCH trial of its Verzenio (abemaciclib) plus an aromatase inhibitor (AI) compared to an AI alone had positive results in HR+, HER2- advanced or metastatic breast cancer. A company [statement](http://investor.lilly.com/news-releases/news-release-details/lilly-present-final-overall-survival-analysis-monarch-3-study?ref=fdaweb.com) says that at eight years of follow-up, MONARCH showed women taking the Verzenio and AI combination had a median overall survival rate higher than that of the control group, although the outcome did not reach statistical significance.

The statement says Verzenio is approved to treat people with certain HR+, HER2- breast cancers in the adjuvant and advanced or metastatic setting. It is the only CDK4/6 inhibitor approved to treat node-positive, high-risk early breast cancer patients, it says.