Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-negative, PR positive status confers therapeutic sensitivity to Letrozole, Palbociclib in patients with Invasive Breast Carcinoma.
The European Medicines Agency (EMA) has authorized palbociclib in combination with an aromatase inhibitor for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. This indication is based on a randomized phase 3 study, PALOMA-2, that evaluated letrozole in combination with either palbociclib or placebo. 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 an aromatase inhibitor.