Reason for request

Extension of indication

No clinical benefit demonstrated in patients with relapsed or refractory mantle cell lymphoma compared to monochemotherapy.


  • REVLIMID now has Marketing Authorisation in the treatment of relapsed or refractory mantle cell lymphoma (MCL). 
  • As a monotherapy, it improved progression-free survival modestly relative to monochemotherapy (cytarabine, gemcitabine, fludarabine, rituximab and chlorambucil)which are no longer involved in current management of relapsed or refractory MCL. No improvement in overall survival was demonstrated compared to these types of monochemotherapy.
  • In patients with relapsed or refractory MCL and presenting high tumour burden, the use of REVLIMID is to be considered only in the absence of available therapeutic alternative and with close monitoring, following the observation of a high proportion of early deaths occurring in the 20 weeks after initiation of lenalidomide treatment in these patients.








Clinical Benefit



Clinical Added Value

no clinical added value


Therapeutic use


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