Brentuximab vedotin

The European Medicines Agency has approved brentuximab vedotin for first-line treatment of anaplastic large cell lymphoma.

European Medicines Agency logo

The European Medicines Agency (EMA) has recently granted a positive opinion for extending the licence of brentuximab vedotin (Adcetris®) to include the treatment of adults with systemic anaplastic large cell lymphoma (ALCL) who have not been treated before. For this indication, brentuximab vedotin is given in combination with chemotherapy with cyclophosphamide, doxorubicin (or hydroxydaunorubicin) and prednisolone (CHP). The positive opinion will now be reviewed by the European Commission to confirm if brentuximab vedotin should be approved as a first-line therapy for systemic ALCL in Europe.

Brentuximab vedotin is an antibody–drug conjugate: an anti-cancer drug joined to an antibody. The antibody targets a protein called CD30 on lymphoma cells and takes the anti-cancer drug directly to them.

ALCL is a type of T-cell lymphoma that can be difficult to treat. A large clinical trial found that, compared to standard CHOP chemotherapy, brentuximab vedotin + CHP significantly improved outcomes for people with T-cell lymphoma who had not been treated before. Most people in the trial had ALCL but 1 in 4 had other types of T-cell lymphoma.

Brentuximab vedotin is already available to treat:

  • adults with systemic ALCL whose lymphoma has relapsed or has not responded to previous treatment
  • people with some types of relapsed or refractory T-cell skin lymphoma who have relapsed or has not responded to previous treatment
  • people with Hodgkin lymphoma that has come back, either after a stem cell transplant, or in people who are not able to have a stem cell transplant.

The new indication provides another option for first-line treatment of ALCL. Although it is good news for people with ALCL, it is disappointing that the licence does not extend to people with other types of T-cell lymphoma, who have limited treatment options.

This decision has the potential to be practice-changing. The ECHELON-2 trial of brentuximab vedotin is the first prospective trial in peripheral T-cell lymphoma to show an overall benefit over standard CHOP therapy.

Brentuximab vedotin is currently being assessed by the National Institute for Health and Care Excellence (NICE), to decide if it should be made available on the NHS for first-line treatment of ALCL. We will report on the outcome when it is announced.

22 April 2020