ADCETRIS (brentuximab vedotin), monoclonal antibody

ONCOLOGY - New indication
Opinions on drugs - Posted on Mar 29 2018

Reason for request

Extension of indication

Substantial clinical benefit in the treatment of CD30+ Hodgkin’s lymphoma with increased risk of relapse or progression following autologous stem cell transplant and minor clinical added value in the management of this disease

 

  • ADCETRIS has Marketing Authorisation in the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT).
  • Its efficacy has been demonstrated compared with placebo in terms of progression-free survival.
  • A gain in overall survival has not been demonstrated to date, and so the benefit of this preventive strategy for post-ASCT recurrence cannot be determined compared with the treatment of the relapse with brentuximab vedotin.
  • Serious adverse events may occur during treatment with brentuximab vedotin.

 

 

 

 

 


Clinical Benefit

Substantial

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Clinical Added Value

minor

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Therapeutic use

-

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