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# FDA Approves Lilly’s Verzenio Breast Cancer Drug
- URL: https://www.fdaweb.com/fda-approves-lillys-verzenio-breast-cancer-drug/
- Published: 2021-10-13T12:00:00.000Z
- Updated: 2026-09-14T17:18:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150355

FDA has approved Lilly’s Verzenio (abemaciclib) to be used in combination with endocrine therapy for the adjuvant treatment of adult patients with HR+, HER2-, node-positive early breast cancer at high risk of recurrence with specified results on an FDA-approved diagnostic test. The company [says](https://www.marketwatch.com/press-release/fda-approves-verzenio-abemaciclib-as-the-first-and-only-cdk46-inhibitor-for-certain-people-with-hr-her2--high-risk-early-breast-cancer-2021-10-13?tesla=y&ref=fdaweb.com) Verzenio is the first CDK4/6 inhibitor approved for this patient population.

The Verzenio labeling contains Warnings and Precautions for diarrhea, neutropenia, interstitial lung disease, hepatotoxicity, venous thromboembolism, and embryo-fetal toxicity.