Regulatory Issues: EMA The EuropeanMedicines Agency Review of Pertuzumab for the Treatment of Adult Patients With HER2-Positive Metastatic or Locally Recurrent Unresectable Breast Cancer: Summary of the Scientific Assessment of the Committee for Medicinal

Disclosures of potential conflicts of interest may be found at the end of this article. Key Words. Pertuzumab x Perjeta x Breast cancer x EMA x European Medicines Agency Pertuzumab is a recombinant humanized monoclonal anti-body that specifically targets the extracellular dimerization domain (subdomain II) ofHER2. Basedon thepositiveopinion from the European Medicines Agency (EMA) on March 4, 2013, a marketing authorization valid throughout the EuropeanUnion (EU) was issued for pertuzumab (Perjeta) for use in combination with trastuzumab and docetaxel for the treatment of adult patients with HER2-positive meta-static or locally recurrent unresectable breast cancer who have not received previous anti-HER2 therapy or chemother-apy for theirmetastatic disease.The demonstration of clinical benefit for pertuzumab was based on a single, phase III