EMA Recommends Extension of Indications for Brentuximab Vedotin

New indication concerns the treatment of adult patients with CD30+ cutaneous T-cell lymphoma after at least one prior systemic therapy

On 9 November 2017, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product brentuximab vedotin (Adcetris).

The marketing authorisation holder for this medicinal product is Takeda Pharma A/S. 

The CHMP adopted a new indication as follows:

Adcetris is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy.  

For information, the full indications for Adcetris will be as follows:

 Adcetris is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):

 • following autologous stem cell transplant (ASCT) or

 • following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.

 Adcetris is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following ASCT.

 Adcetris is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma.

 Adcetris is indicated for the treatment of adult patients with CD30+ CTCL after at least 1 prior systemic therapy.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

 Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.