Verzenios (abemaciclib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Eli Lilly Nederland B.V. Verzenios (abemaciclib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/verzenios-epar-product-information_en.pdf. Revised March 2024. Accessed March 25, 2024.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
Verzenios in combination with endocrine therapy is indicated 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.	3
Verzenios is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.	9

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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