Seattle Genetics, Inc. (SGEN) announced that the FDA has accepted for filing a supplement to the Biologics License Application, supporting the use of ADCETRIS for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma, or HL, and systemic anaplastic large cell lymphoma, or sALCL.
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 FDA is expected to take action on the application by September 14, 2013.
For comments and feedback: editorial@rttnews.com