Regulatory approval

Published by the Food and Drug Administration.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	ER positive, HER2-negative	Invasive Breast Carcinoma	Abemaciclib, Anastrozole
Sensitivity (+)	HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Anastrozole
Sensitivity (+)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Anastrozole
Sensitivity (+)	ER positive, HER2-negative	Invasive Breast Carcinoma	Abemaciclib, Letrozole
Sensitivity (+)	HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Letrozole
Sensitivity (+)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Letrozole