Adcetris

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Questions & Answers

On 9 November 2017, the 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 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 (see section 5.1)."

For information, the full indications for Adcetris will be as follows1:

"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 (see section 5.1).

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

Adcetris is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy (see section 5.1)."

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), 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.


1 New text in bold

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Adcetris (II-48) (English only) 2017-11-10  

Key facts

Product details for Adcetris
NameAdcetris
INN or common name

brentuximab vedotin

Therapeutic area Hodgkin DiseaseLymphoma, Non-Hodgkin
Active substance

brentuximab vedotin

Date opinion adopted09/11/2017
Company name

Takeda Pharma A/S

StatusPositive
Application typePost authorisation