Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER positive, HER2-negative, PR positive status confers therapeutic sensitivity to Abemaciclib, Tamoxifen in patients with Invasive Breast Carcinoma.
The Republic of Ireland's Health Service Executive (HSE) has approved abemaciclib in combination with endocrine therapy for reimbursement as a treatment option for the adjuvant treatment of hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence in adult patients. According to the European Medicine Agency's product information for abemaciclib, this indication was approved based on results from the monarchE study, a randomized, open label, two cohort, phase 3 study which enrolled a total of 5,637 patients who were randomized in a 1:1 ratio to receive 2 years of abemaciclib plus physician's choice of standard endocrine therapy, or standard endocrine therapy alone. Initial endocrine therapy received by patients included letrozole (39%), tamoxifen (31%), anastrozole (22%), or exemestane (8%) in monarchE (NCT03155997).
This statement is based on a regulatory approval from the Health Service Executive:
Abemaciclib in combination with endocrine therapy 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.