Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER positive, HER2-negative, PR positive status confers therapeutic sensitivity to Abemaciclib in patients with Invasive Breast Carcinoma.
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.
This statement is based on a regulatory approval from the Health Canada:
VERZENIO (abemaciclib) is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor in postmenopausal women as initial endocrine-based therapy, in combination with fulvestrant in women with disease progression following endocrine therapy, or as a single agent in women with disease progression following endocrine therapy and at least 2 prior chemotherapy regimens.