Therapeutic Response

ER positive and HER2-negative status confers therapeutic sensitivity to Abemaciclib in combination with Fulvestrant in patients with Invasive Breast Carcinoma.

Statements

Source and description
Faslodex (fulvestrant) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to fulvestrant in combination with either palbociclib or abemaciclib for the treatment of patients who are women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer with disease after endocrine therapy.
Verzenio (abemaciclib) [package insert]. FDA. The U.S. Food and Drug Administration (FDA) granted approval to abemaciclib in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
Verzenios (abemaciclib) [product information]. EMA. The European Medicines Agency (EMA) has authorized abemaciclib in combination with endocrine therapy and an aromatase inhibitor or fulvestrant as an initial endocrine-based therapy, or in women who have received prior endocrine therapy, for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Abemaciclib's product information further states that in pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist. This indication is based on the randomized, double-blind, placebo-controlled phase 3 study MONARCH 3 that used either anastrozole or letrozole as an aromatase inhibitor.