Biotechnology News : FDA - SGEN by 9/14/13 POSTED.
The FDA is expected to take action on the application by September 14, 2013. ADCETRIS is an antibody-drug conjugate (ADC) 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.
“Our goal is to broaden the ADCETRIS U.S. labeling claims to provide both patients and physicians the opportunity to incorporate ADCETRIS into additional HL and sALCL treatment settings,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “The FDA’s acceptance of our sBLA
submission is an important step towards making ADCETRIS available in the retreatment and extended duration setting, and we look forward to the regulatory outcome.”