Seagen Inc (SGEN)

[surf1944]

8:52AM Seattle Genetics announces FDA Advisory Committee to review Brentuximab Vedotin for the treatment of relapsed or refractory Hodgkin Lymphoma and systemic ALCL (SGEN) 19.35 : Co announces that the FDA's Oncologic Drugs Advisory Committee will review its 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... 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