EU approves label variation for Adcetris (brentuximab vedotin) in Hodgkin lymphoma and systemic anaplastic large cell lymphoma (sALCL)- Takeda

The European Commission (EC) has approved a Type II variation for Adcetris (brentuximab vedotin). from Takeda, 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. The decision from the EC follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in October 2015.

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.

The Type II variation is based on data from the Phase II SGN35-006 Part A study that demonstrated effective anti-tumor 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 II studies (SGN35-003 and SGN35-004).