The European Medicines 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 Products for Human Use

• Published in: The oncologist (Dayton, Ohio) Vol. 19; no. 7; pp. 766 - 773
• Main Authors: Boix‐Perales, Hector, Borregaard, Jeanett, Jensen, Kristina Bech, Ersbøll, Jens, Galluzzo, Sara, Giuliani, Rosa, Ciceroni, Cinzia, Melchiorri, Daniela, Salmonson, Tomas, Bergh, Jonas, Schellens, Jan H., Pignatti, Francesco
• Format: Journal Article
• Language: English
• Published: Durham, NC, USA AlphaMed Press 01.07.2014
• Subjects: Antibodies, Monoclonal, Humanized - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Breast cancer; Breast Neoplasms - drug therapy; EMA; European Medicines Agency; European Union; Female; Humans; Medicin och hälsovetenskap; Middle Aged; Neoplasm Recurrence, Local - drug therapy; Perjeta; Pertuzumab; Regulatory Issues: EMA; Survival Analysis; EMA; Perjeta; Breast cancer; Pertuzumab; European Medicines Agency

Pertuzumab is a recombinant humanized monoclonal antibody that specifically targets the extracellular dimerization domain (subdomain II) of HER2. Based on the positive opinion from the European Medicines Agency (EMA) on March 4, 2013, a marketing authorization valid throughout the European Union (EU...