Seattle Genetics, Inc. SGEN today announced that the Oncologic Drugs
Advisory Committee to the U.S. Food and Drug Administration voted
10-0 to recommend that the FDA grant accelerated approval of ADCETRIS for the treatment of patients with Hodgkin lymphoma who
relapse after autologous stem cell transplant.
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.
The FDA is expected to act on the two Biologics License
Applications for ADCETRIS by August 30, 2011 under the Prescription
Drug User Fee Act. ADCETRIS is an antibody-drug conjugate directed to CD30, a defining marker of Hodgkin lymphoma and ALCL.
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