Seattle Genetics, Inc. (SGEN) said the U.S. Food and Drug Administration has accepted for filing a supplemental Biologics License Application for ADCETRIS (brentuximab vedotin) in the AETHERA setting for the post-transplant consolidation treatment of Hodgkin lymphoma patients at high risk of relapse or progression.
The FDA granted priority review for the application and the Prescription Drug User Fee Act target action date is August 18.
The submission of the supplemental BLA is based on positive results from a phase 3 clinical trial called AETHERA.
The trial was designed to determine if 16 cycles of ADCETRIS as consolidation therapy immediately following an autologous stem cell transplant could extend progression-free survival in Hodgkin lymphoma patients at high risk of relapse or progression.
ADCETRIS is an antibody-drug conjugate directed to CD30, which is expressed in classical Hodgkin lymphoma and systemic anaplastic large cell lymphoma or sALCL, as well as other lymphoma subtypes.
ADCETRIS is approved in relapsed Hodgkin lymphoma and sALCL but is currently not approved for consolidation therapy in Hodgkin lymphoma patients immediately after autologous stem cell transplant.
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