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 |
- |
Clinical Added Value
minor |
- |
Therapeutic use
- |
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