Regulatory approval

Published by the Food and Drug Administration. Approved

Verzenio is a kinase inhibitor indicated as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.

This is written in the approval document.

Citation

Eli and Lily Company. Verzenio (abemaciclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208716s010s011lbl.pdf. Revised March 2023. Accessed October 30, 2024.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
FDA (1) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib
FDA (1) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib
FDA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib