FDA Advisory Panel Recommends Approval of Drug for Preoperative Treatment of Breast Cancer

• Autores: Jill Jin
• Localización: JAMA: the journal of the American Medical Association, ISSN 0098-7484, Vol. 310, Nº. 14, 2013, pág. 1434
• Idioma: inglés
• Texto completo no disponible (Saber más ...)
• Resumen

  • In a nearly unanimous vote, an advisory panel for the US Food and Drug Administration (FDA) voiced its support on September 12 for the approval of the drug pertuzumab for use in the neoadjuvant (preoperative) treatment of breast cancer.

    Pertuzumab, a monoclonal antibody targeting the HER2/neu receptor, was approved by the FDA in 2012 for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who had not received prior anti-HER2 therapy or chemotherapy. If the FDA takes its advisory panel�s advice, pertuzumab would also be approved for use as neoadjuvant treatment in early HER2-positive breast cancers.