Reason for request

Extension of indication

No clinical benefit demonstrated, in relapsing or refractory Hodgkin lymphoma after autologous haematopoietic stem cell transplant and treatment with brentuximab vedotin, compared with the current strategy


  • OPDIVO now has Marketing Authorisation in the treatment of adults with relapsing or refractory classical Hodgkin lymphoma (cHL) after autologous haematopoieticstem cell transplant (ASCT) and treatment with brentuximab vedotin (ADCETRIS).
  • Its efficacy has been established by a non-comparative study showing a high objective response rate (nearly 70%)
  • Acute graft-versus-host reactions and deaths related to the transplant were observed, more frequently than expected, in patients who received an allograft after nivolumab treatment. The existence of this potential additional risk justifies setting up nivolumab treatment in the context of multidisciplinary meetings including haematologists specialised in stem-cell transplants.



Clinical Benefit



Clinical Added Value

no clinical added value


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