Seattle Genetics Inc. (SGEN) Thursday announced that the Oncologic Drugs Advisory Committee to the U.S. Food and Drug Administration voted 10-0 to recommend the granting of accelerated approval of Adcetris for the treatment of patients with Hodgkin lymphoma who relapse after autologous stem cell transplant.
In addition, the Oncologic Drugs Advisory Committee or 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 or ALCL.
Adcetris is an antibody-drug conjugate directed to CD30, a defining marker of Hodgkin lymphoma and ALCL.
The FDA is expected to act on the two Biologics License Applications or BLAs for Adcetris by August 30, 2011 under the Prescription Drug User Fee Act.
The Adcetris BLAs were based primarily on data from a pivotal trial in relapsed or refractory Hodgkin lymphoma that was conducted under a Special Protocol Assessment with the FDA and from a phase II trial in relapsed or refractory systemic ALCL.
The FDA is not obligated to follow the guidance of advisory committee panels but normally takes its advice into consideration before making its final decision on approval.
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