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
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 |