Therapeutic Response

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

Statements

Source and description
Ibrance (palbociclib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to palbociclib in combination with an aromatase inhibitor as an initial endocrine-based therapy for treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This indication is based on PALOMA-2 (NCT01740427), an international, randomized, double-blind, parallel-group, multicenter study of palbociclib plus letrozole versus placebo plus letrozole.
Ibrance (palbociclib) [product information]. EMA. 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.