Regulatory approval

Published by the Food and Drug Administration. Approved

Verzenio is a kinase inhibitor indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

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, Anastrozole
FDA (1) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Anastrozole
FDA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Anastrozole
FDA (1) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Letrozole
FDA (1) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Letrozole
FDA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Letrozole