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EMA Recommends Extension of Indications for Brentuximab Vedotin

New indication concerns the treatment of previously untreated systemic anaplastic large cell lymphoma
02 Apr 2020
Anticancer agents & Biologic therapy;  Haematologic malignancies

On 26 March 2020, 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 in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL).

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

Hodgkin lymphoma (HL)

ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage IV HL in combination with doxorubicin, vinblastine and dacarbazine.

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).

ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ HL:

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

sALCL

ADCETRIS in combination with CHP is indicated for adult patients with previously untreated sALCL.

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

Cutaneous T-cell lymphoma (CTCL)

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 Adcetris.

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