Seattle Genetics Announces FDA Advisory Committee to Review Brentuximab Vedotin for the Treatment of Relapsed or Refractory Hodgkin Lymphoma and Systemic ALCL

Seattle Genetics, Inc. SGEN today announced that the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee will review the company's Biologics License Applications for brentuximab vedotin on July 14, 2011. ODAC plans to review the BLA for the treatment of relapsed or refractory Hodgkin lymphoma during the morning session and the BLA for the treatment of relapsed or refractory systemic anaplastic large cell lymphoma during the afternoon session. Brentuximab vedotin is an antibody-drug conjugate directed to CD30, a defining marker of Hodgkin lymphoma and ALCL. ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes appropriate recommendations to the FDA. The FDA regulations indicate that although the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made by the FDA solely, and the recommendations by the panel are non-binding.