EU approves Adcetris (brentuximab vedotin) for CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplant- Takeda

Takeda Pharmaceutical Company has received marketing authorization by the European Commission for Adcetris (brentuximab vedotin) for the treatment of adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplant (ASCT).

The approval is based on a phase III clinical trial called AETHERA that was designed to compare up to 16 cycles (approximately one year) of Adcetris therapy administered every three weeks following ASCT to placebo. This label expansion represents the third indication for Adcetris in the European Union (EU), and follows FDA approval in August 2015 for a similar label based on the AETHERA clinical trial.

Comment: Adcetris was granted conditional marketing authorization by the European Commission in October 2012 for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. In January 2016, the European Commission approved a Type II variation to include data on the retreatment of adult patients with Hodgkin lymphoma or sALCL who previously responded to Adcetris and who later relapse. Adcetris has received marketing authorization by regulatory authorities in more than 60 countries.