Brentuximab vedotin is an antibody-drug conjugate (ADC) directed against the tumour necrosis factor (TNF) receptor CD30 which is expressed on the surface of tumour cells in haematological malignancies including Hodgkin's lymphoma (HL) and anaplastic large cell lymphoma (ALCL). Brentuximab is indicated for the treatment or relapses or refractory HL after failure of at least two prior multi-agent chemotherapy regimens and for the treatment of relapsed systemic ALCL (sALCL) after at least one prior multi-agent chemotherapy regimen. In Europe, brentuximab is currently under marketing authorisation review for these two indications and in the US, it was approved in August 2011 for these two indications based on response rates observed in two single-arm phase II studies – one in HL (n=102) and one in sALCL (n=58). Overall, the response rates (75% and 86% in HL and sALCL, respectively) in both trials were considered as clinically relevant. Complete remissions were achieved by 34% and 57% in HL and sALCL patients, respectively. Duration of ORR was 6.7 months and 12.6 months in HL and sALCL patients, respectively. Overall, the small population included and the single-arm design, as well as the primary efficacy endpoint 'response rate' do not allow full characterisation of the safety and efficacy profile of brentuximab vedotin based on the available data.