Takeda Pharmaceutical Company Limited announced that the European Commission (EC) has extended the current conditional marketing authorization of ADCETRIS® (brentuximab vedotin) and approved ADCETRIS for the treatment of adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplant (ASCT). The decision follows a positive opinion from the Committee for Medicinal Products for Human Use on May 26, 2016.
“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.”
The AETHERA trial is the first completed randomized 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.
“The AETHERA Phase 3 data further reinforces the role of ADCETRIS in earlier line treatment and may offer new hope for post-transplant Hodgkin lymphoma patients,” said Dirk Huebner, M.D., Executive Medical Director, Oncology Therapeutic Area Unit, Takeda Pharmaceutical Company. “The European Commission decision is a significant milestone for patients who are at risk of relapse following stem-cell transplant as ADCETRIS provides a treatment where none currently exists.”
The AETHERA 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 (hazard ratio=0.57; p-value=0.001), 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 (per independent review committee; HR=0.58; 95%CI (0.41,0.81). A pre-specified interim analysis of overall survival showed no statistically significant difference between the treatment arms. The most common adverse reactions (≥1/10) seen across all trials were infection, upper respiratory tract infection, neutropenia, peripheral neuropathy (sensory and motor), cough, dyspnea, diarrhea, nausea, vomiting, constipation, abdominal pain, alopecia, pruritus, myalgia, arthralgia, fatigue, chills, pyrexia, infusion-related reactions and weight decrease. The safety profile of ADCETRIS in the AETHERA trial was generally consistent with the existing prescribing information.
This decision by the European Commission means that ADCETRIS is now approved for marketing of this indication in the 28 member states of the European Union, Norway, Liechtenstein and Iceland.