Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER positive, HER2-negative status confers therapeutic sensitivity to Abemaciclib, Fulvestrant in patients with Invasive Breast Carcinoma.
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.
This statement is based on a regulatory approval from the European Medicines Agency:
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.