The US Food and Drug Administration (FDA) has granted accelerated approval for the cyclin-dependent kinase (4/6) inhibitor palbociclib, or Ibrance, to be used in combination with letrozole for the treatment of postmenopausal women who have estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative metastatic breast cancer and who have not yet received an endocrine-based therapy. Continued approval for this indication may be contingent on positive results from a confirmatory phase 3 trial, PALOMA-2, which is now fully enrolled.
Hampton T. New Drug Approved to Treat Metastatic Breast Cancer. JAMA. 2015;313(12):1199. doi:10.1001/jama.2015.2195