Takeda has received European Commission approval for the expanded use of Adcetris as a consolidation treatment in post-transplant Hodgkin lymphoma.
The regulator has cleared the drug's use for the treatment of adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplant (ASCT).
"Relapse is a devastating event for patients with Hodgkin lymphoma and their families. Not only is the emotional impact significant, but the challenge of treating their disease becomes much greater," said Professor Andreas Engert, M.D., University Hospital of Cologne, Germany.
"For the first time, physicians in the European Union will now have a well-tolerated and effective treatment option that may be used immediately post-transplant to reduce the risk of relapse for Hodgkin lymphoma patients at increased risk."
Approval came on the back of data from the AETHERA trial, which showed that patients with Hodgkin lymphoma who received the drug (plus best supportive care) immediately following ASCT lived significantly longer without disease progression compared those in the placebo-based arm, with a 75 percent improvement in progression-free survival.
Adcetris (brentuximab vedotin) was granted conditional marketing authorisation in Europe back in October 2012 for two indications: the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option; and the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).