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.

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.