EC extends conditional marketing authorisation for Adcetris

The European Commission (EC) has extended the current conditional marketing authorisation of Takeda’s Adcetris (brentuximab vedotin) and approved the therapy 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,” commented 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.”

The approval was based on data from the AETHERA Phase III trial. The trial demonstrated that patients with Hodgkin lymphoma who received Adcetris (plus best supportive care) as consolidation therapy immediately following ASCT lived significantly longer without disease progression compared to patients who received placebo (plus best supportive care) as assessed by an independent review committee, which equates to a 75 percent improvement in PFS. PFS was assessed after a minimum of two years post initiation of treatment for all study patients. An updated analysis conducted after three years of follow up showed sustained PFS improvement. A pre-specified interim analysis of overall survival showed no statistically significant difference between the treatment arms.

A “significant milestone” for those at increased risk of relapse

The AETHERA trial is the first completed randomised study that has explored consolidation treatment immediately following ASCT as a way of extending the effect of transplant for prevention of relapse among people with Hodgkin lymphoma.

Dirk Huebner, M.D., Executive Medical Director, Oncology Therapeutic Area Unit, Takeda, commented “The AETHERA Phase III data further reinforces the role of Adcetris in earlier line treatment and may offer new hope for post-transplant Hodgkin lymphoma patients. The European Commission decision is a significant milestone for patients who are at increased risk of relapse following stem-cell transplant as Adcetris provides a treatment where none currently exists.”

In January 2016, the EC also approved a Type II variation for Adcetris to include data on the retreatment of adult patients with relapsed or refractory (R/R) Hodgkin lymphoma or R/R systemic anaplastic large cell lymphoma (sALCL) who previously responded to Adcetris and who later relapsed.