25 July 2017 - Approval based on positive phase 3 AETHERA clinical trial results.
Seattle Genetics today announced that Health Canada has issued a non-conditional marketing authorization for use of Adcetris as post-autologous stem cell transplant (ASCT) consolidation treatment of patients with Hodgkin lymphoma (HL) at increased risk of relapse or progression.
The indication was based on positive results from the phase 3 AETHERA clinical trial. Adcentris previously received approval with conditions in Canada for two lymphoma indications: HL patients who relapse after ASCT or relapse after at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates; and for systemic anaplastic large cell lymphoma (sALCL) patients who relapse after at least one multi-agent chemotherapy regimen.