Adcetris - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

brentuximab vedotin

Opinion

On 25 April 2025, 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 to include treatment of adults with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV Hodgkin lymphoma, in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone.The full indications for Adcetris will therefore be as follows:¹

Hodgkin lymphoma

Adcetris is indicated for adult patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD). (see sections 4.2 and 5.1).

Adcetris is indicated for adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV HL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD)(see sections 4.2 and 5.1).

Adcetris is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT) (see section 5.1).

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

1. following ASCT, or
2. following at least two prior therapies when ASCT or multi‑agent chemotherapy is not a treatment option.

Systemic anaplastic large cell lymphoma

Adcetris in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) (see section 5.1).

Adcetris is indicated for the treatment of adult patients with relapsed or refractory sALCL.

Cutaneous T‑cell lymphoma

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 on the EMA website 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

CHMP post-authorisation summary of positive opinion for Adcetris (II-111)

AdoptedReference Number: EMA/CHMP/125287/2025

Key facts

• Name of medicine:
  Adcetris
• EMA product number:
  EMEA/H/C/002455
• Active substance:
  Brentuximab vedotin
• International non-proprietary name (INN) or common name:
  brentuximab vedotin
• Therapeutic area (MeSH):
  • Lymphoma, Non-Hodgkin
  • Hodgkin Disease
• Anatomical therapeutical chemical (ATC) code:
  L01XC12
• Marketing authorisation holder:
  Takeda Pharma A/S
• Date of opinion:
  25/04/2025
• Status:
  Positive