Reason for request

Extension of indication

High clinical benefit in relapsed or refractory classical Hodgkin’s lymphoma after failure of autologous stem cell transplantation (ASCT) and brentuximab vedotin (BV) treatment, or in the event of transplantation ineligibility after BV treatment failure, though no demonstrated clinical added value in the therapeutic strategy.

 

  • KEYTRUDA has been granted marketing authorisation for the treatment of adults with relapsed or refractory classical Hodgkin’s lymphoma (HLc) in 2 situations: after failure of autologous stem cell transplantation (ASCT) and brentuximab vedotin (BV) failure, or in patients ineligible for transplantation and after BV treatment failure.

  • Its efficacy was established by a non-comparative, multi-cohort study demonstrating that a high objective response rate (between 66.7 and 75.4%) was obtained over a median follow-up period of 15.9 months.

  • Acute graft-versus-host disease, along with ASCT-related deaths, were observed, more frequently than expected, in patients receiving an allograft following pembrolizumab treatment. This excess risk justifies the need for a multidisciplinary review meeting, including haematologists specialising in  stem cell transplantation, before initiation of pembrolizumab treatment.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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