Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration (FDA) granted approval to abemaciclib in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative, node positive, early breast cancer at high risk of recurrence. This indication is based on the monarchE (NCT03155997) clinical trial, which was a randomized (1:1), open-label, two cohort, multicenter study. Initial endocrine therapy received by patients included letrozole (39%), tamoxifen (31%), anastrozole (22%), or exemestane (8%).

This is written in the approval document as:

Verzenio is a kinase inhibitor indicated in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node positive, early breast cancer at high risk of recurrence.

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.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
FDA (1) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Tamoxifen
FDA (1) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Tamoxifen
FDA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Tamoxifen
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
FDA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Exemestane
FDA (1) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Exemestane
FDA (1) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Exemestane