HER2-targeted therapies have revolutionized the outcome of patients with HER2-positive breast cancer. Pertuzumab is the first in a new class of monoclonal antibodies that target the extracellular dimerization domain of HER2 receptors, also known as HER dimerization inhibitors. The development of pertuzumab and preclinical and clinical data in breast cancer are reviewed. Regulatory affairs related to pertuzumab and the recent accelerated approval granted by the FDA for the treatment of breast cancer in the neoadjuvant setting are also covered. This process opens doors for further approvals which could considerably shorten the time between initial drug development and availability.
Keywords: Breast cancer; Dimerization inhibitor; HER2-targeted therapy; Monoclonal antibody; Pertuzumab.