Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-negative, PR positive status confers therapeutic sensitivity to Fulvestrant, Palbociclib in patients with Invasive Breast Carcinoma.
The European Medicines Agency (EMA) has authorized palbociclib in combination with fulvestrant for patients who are women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, who have also received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.
This statement is based on a regulatory approval from the European Medicines Agency:
IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with fulvestrant in women who have received prior endocrine therapy.