EC approves Type II variation for Takeda’s Adcetris

The European Commission has approved a Type II variation for Takeda’s Adcetris (brentuximab vedotin) 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 relapse.

Adcetris was granted conditional marketing authorisation by the EC in 2012 for the treatment of R/R CD30+ Hodgkin lymphoma following autologous stem cell transplant (ASCT), or at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and for R/R sALCL.

The SmPC variation includes an update to the clinical sections, including safety, to include data on retreatment of adult patients who have responded to previous treatment with Adcetris (CR or PR) under the existing indications, but later relapsed.

Type II variation based on the SGN35-006 Part A study

The Type II variation is based on data from the Phase 2 SGN35-006 Part A study that demonstrated effective anti-tumour responses can be achieved in the majority of R/R Hodgkin lymphoma and sALCL patients with Adcetris retreatment. The safety and efficacy results from this trial were consistent with the positive profile demonstrated in the pivotal Phase 2 studies (SGN35-003 and SGN35-004).

Commenting on the announcement, Professor Anton Hagenbeek, M.D., Ph.D., Professor of Haematology, Department of Haematology, Academic Medical Centre in the University of Amsterdam, said, “Adcetris has transformed the treatment landscape for relapsed/refractory Hodgkin lymphoma and sALCL patients in Europe, and has emerged as a most valuable tool to induce a remission. However, lymphoma is a relentless disease, and relapse occurs in some of these very difficult to treat patients. Now, with the opportunity for retreatment, we can offer patients with very limited options another chance to potentially benefit from Adcetris.”

Dirk Huebner, M.D., Executive Medical Director, Oncology Therapeutic Area Unit, Takeda, added, “The EC decision to include data on retreatment in the Adectris label is important in advancing care for patients battling these diseases.”