Seattle Genetics (SGEN) Announces FDA Advisory Committee in Favor of Accelerated Approval of ADCETRIS

Seattle Genetics, Inc. (Nasdaq: SGEN) announced that the Oncologic Drugs Advisory Committee (ODAC) to the U.S. Food and Drug Administration (FDA) voted 10-0 to recommend that the FDA grant accelerated approval of ADCETRIS™ (brentuximab vedotin) for the treatment of patients with Hodgkin lymphoma who relapse after autologous stem cell transplant (ASCT). In addition, ODAC voted 10-0 to recommend that the FDA grant accelerated approval of ADCETRIS for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). The FDA is expected to act on the two Biologics License Applications (BLAs) for ADCETRIS by August 30, 2011 under the Prescription Drug User Fee Act (PDUFA). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of Hodgkin lymphoma and ALCL.

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