Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER positive, HER2-negative, PR positive status confers therapeutic sensitivity to Abemaciclib, Fulvestrant in patients with Invasive Breast Carcinoma.
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.
This statement is based on a regulatory approval from the Food and Drug Administration:
FASLODEX is an estrogen receptor antagonist indicated for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.