BioCentury
ARTICLE | Clinical News

Adcetris brentuximab vedotin regulatory update

February 23, 2015 8:00 AM UTC

Seattle Genetics submitted an sBLA to FDA for Adcetris brentuximab vedotin as consolidation therapy immediately following an autologous stem cell transplant (ASCT) in Hodgkin’s lymphoma (HL) patients at high risk of relapse. Adcetris has accelerated approval from FDA to treat HL after failure of ASCT or after failure of >=2 prior multi-agent chemotherapy regimens in patients who are not ASCT candidates and to treat systemic anaplastic large cell lymphoma (ALCL) after failure of >=1 prior multi-agent chemotherapy regimen. The antibody-drug conjugate (ADC) composed of an anti- CD30 mAb and monomethyl auristatin E (MMAE) also has conditional approval in the EU. ...