Brentuximab vedotin regulatory update

FDA approved an sBLA from Seattle Genetics for Adcetris brentuximab vedotin as consolidation therapy following autologous hematopoietic stem cell transplant (HSCT) in patients with classical Hodgkin’s lymphoma (HL) at high risk of relapse or progression. The approval is based on data from the Phase III AETHERA trial (see BioCentury, Dec. 15, 2014). FDA also converted Adcetris’ accelerated approval to full approval to treat HL after failure of autologous HSCT or after failure of >=2 prior multi-agent chemotherapy regimens in patients who are not autologous HSCT candidates based on AETHERA data. Adcetris still has accelerated approval to treat systemic anaplastic large cell lymphoma (ALCL) after failure of >=1 prior multi-agent chemotherapy regimen.

Seattle Genetics said the AETHERA data have been submitted to EMA and Health Canada. The product has conditional approval in the EU and Canada (see BioCentury, Nov. 5, 2012 & Feb. 11, 2013). ...