Reason for request

Re-assessment of the improvement in actual benefit

Minor improvement in the treatment of mantle cell lymphoma

  • VELCADE now has Marketing Authorisation in combination with rituximab, cyclophosphamide, doxorubicin and prednisone in the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
  • VELCADE in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (VcR-CAP) has shown an improvement in progression-free survival (a gain in absolute terms of 10.3 months) by comparison with vincristine in combination with these same medicines (R-CHOP) to the detriment of the safety profile, which is less favourable.
  • No benefit in terms of overall survival has been demonstrated to date.

 


Clinical Benefit

Substantial

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Clinical Added Value

minor

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Therapeutic use

-

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