Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration (FDA) granted approval to abemaciclib in combination with an aromatase inhibitor as an initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative advanced or metastatic breast cancer. This indication is based on the MONARCH 3 (NCT02246621) clinical trial, which was a randomized (2:1), double-blinded, placebo-controlled, multicenter study. A total of 493 patients were randomized to receive 150 mg abemaciclib or placebo orally twice daily, plus physician's choice of letrozole (80% of patients) or anastrozole (20%).

This is written in the approval document as:

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.

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.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	ER positive, HER2-negative	Invasive Breast Carcinoma	Abemaciclib, Anastrozole
FDA (2)	HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Anastrozole
FDA (2)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Anastrozole
FDA (2)	ER positive, HER2-negative	Invasive Breast Carcinoma	Abemaciclib, Letrozole
FDA (2)	HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Letrozole
FDA (2)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Letrozole

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2018-08-17	Food and Drug Administration	Indication received traditional approval.