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Seattle Genetics submits sBLA to FDA for ADCETRIS

Seattle Genetics has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration supporting the use of ADCETRIS for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma and systemic anaplastic large cell lymphoma. ADCETRIS is an antibody-drug conjugate directed to CD30, a defining marker of HL and sALCL, that was granted accelerated approval by the FDA in August 2011 for relapsed HL and relapsed sALCL. The sBLA is based on results from a phase II clinical trial with two treatment arms. One arm evaluated retreatment with ADCETRIS in patients who previously responded to treatment with ADCETRIS, then discontinued treatment and subsequently had disease progression or relapse. The other arm allowed treatment extension and evaluated prolonged treatment with ADCETRIS beyond 16 cycles of therapy. The sBLA submission includes updated data sets from this phase II trial. Preliminary data from this trial were previously reported at the 2011 American Society of Hematology Annual Meeting and at the 2012 American Society of Clinical Oncology Annual meeting.