Therapeutic Response

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

Statements

Source and description
Verzenio (abemaciclib) [product monograph]. HC. Health Canada approved abemaciclib in combination with an aromatase inhibitor, in combination with fulvestrant, or as a single agent for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in postmenopausal women as initial endocrine-based therapy, in women with disease progression following endocrine therapy, or in women with disease progression following endocrine therapy and at least two prior chemotherapy regimens.
Verzenio (abemaciclib) [package insert]. FDA. The U.S. Food and Drug Administration (FDA) granted approval to abemaciclib in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative, node positive, early breast cancer at high risk of recurrence. This indication is based on the monarchE (NCT03155997) clinical trial, which was a randomized (1:1), open-label, two cohort, multicenter study. Initial endocrine therapy received by patients included letrozole (39%), tamoxifen (31%), anastrozole (22%), or exemestane (8%).